510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JRWClass I

Antisera, Fluorescent, B. Parapertussis

21 CFR 866.3065 / Microbiology
FDA source (opens on fda.gov)

JRW is the FDA product code for Antisera, Fluorescent, B. Parapertussis, a class I device type, regulated under 21 CFR 866.3065. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JRW
Device name
Antisera, Fluorescent, B. Parapertussis
Regulation
21 CFR 866.3065
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code JRW

By decision year
2 clearances under product code JRW with a decision year between 1976 and 1978, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JRW by decision year
YearClearances
19761
19781

Applicants with the most clearances

Product code JRW
Applicants holding the most 510(k) clearances under product code JRW
ApplicantClearances
Beckman Instruments, Inc.1
Royal Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JRW.