Medical device manufacturer

Otisville Biotech, Inc.

Otisville Biotech, Inc. holds 98 FDA 510(k) clearances across 12 product codes. Median elapsed review time is 21 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 98
Product codes: 12
Median review: 21 days
Recall records: 0

How does FDA spell Otisville Biotech, Inc.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Otisville Biotech, Inc. file in?

12 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
JSJ	Culture Media, Selective And Non-Differential	23	21 days	3 July 1986
JSI	Culture Media, Selective And Differential	20	21 days	3 July 1986
JSG	Culture Media, Non-Selective And Non-Differential	17	21 days	24 February 1986
JSH	Culture Media, Non-Selective And Differential	9	21 days	3 July 1986
JSE	Culture Media, Multiple Biochemical Test	7	21 days	3 July 1986
JTY	Culture Media, For Isolation Of Pathogenic Neisseria	5	30 days	24 February 1986
JSF	Culture Media, Single Biochemical Test	4	9 days	3 July 1986
KZI	Culture Media, Enriched	4	14 days	3 July 1986
JJY	Multi-Analyte Controls, All Kinds (Assayed)	2	71 days	17 April 1984
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	2	35 days	13 February 1984
JTL	Plasma, Coagulase, Human, Horse And Rabbit	1	31 days	8 December 1983
JTO	Discs, Strips And Reagents, Microorganism Differentiation	1	21 days	24 February 1986

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Otisville Biotech, Inc. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Otisville Biotech, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K862400	BIOTIS KV LAKED BLOOD AGAR	JSJ	3 July 1986	9
K862399	BIOTIS SXT AGAR	JSJ	3 July 1986	9
K862398	BIOTIS DECARBOXYLASE MEDIA, ORNITHINE	JSF	3 July 1986	9
K862397	BIOTIS DECARBOXYLASE MEDIA, LYSINE	JSF	3 July 1986	9
K862396	BIOTIS DECARBOXYLASE MEDIA, ARGININE	JSF	3 July 1986	9
K862395	BIOTIS DECARBOXYLASE MEDIA, BASE	JSH	3 July 1986	9
K862394	BIOTIS MITIS SALIVARIUS	JSI	3 July 1986	9
K862393	BIOTIS LITMUS MILK	JSE	3 July 1986	9
K862392	BIOTIS MOTILITY TEST MEDIUM	JSF	3 July 1986	9
K862391	BIOTIS DESOXYCHOLATE AGAR	JSI	3 July 1986	9

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.