Skip to content

Medical device manufacturer

J R Scientific

J R Scientific holds 132 FDA 510(k) clearances across 1 product codes. Median elapsed review time is 16 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
132
Product codes
1
Median review
16 days
Recall records
0

How does FDA spell J R Scientific?

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

Which product codes does J R Scientific file in?

1 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.
CodeDeviceClearancesMedian reviewLatest
KITMedia And Components, Synthetic Cell And Tissue Culture13216 days

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

Has J R Scientific 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

What has J R Scientific cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K883951MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)KIT11
K883632EX-CELL 300TM, CATALOG NO. 210-3575KIT16
K883631EX-CELL 300TM, CATALOG # 210-3579KIT16
K883630RPMI-1640 MEDIUM, CATALOG NO. 210-3525KIT16
K883629HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013KIT16
K883628MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051KIT16
K883627MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150KIT16
K883626EX-CELL 301, CATALOG NO. 210-3577KIT16
K883625EX-CELL 301, CATALOG NO. 200-3651KIT16
K883624EX-CELL 300TM, CATALOG NO. 200-3601KIT16

Source: openFDA device/510k · retrieved

Watch what J R Scientific files next

Get an email when this company clears a new device, or when anything is recalled in a product code you follow.

Start watching with DeviceSignal

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.