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

Antigen, Cf, Psittacosis (Chlamydia Group)

21 CFR 866.3120 / Microbiology
FDA source (opens on fda.gov)

GPW is the FDA product code for Antigen, Cf, Psittacosis (Chlamydia Group), a class I device type, regulated under 21 CFR 866.3120. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GPW
Device name
Antigen, Cf, Psittacosis (Chlamydia Group)
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code GPW

By decision year
4 clearances under product code GPW with a decision year between 1981 and 1987, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GPW by decision year
YearClearances
19811
19852
19871

Applicants with the most clearances

Product code GPW
Applicants holding the most 510(k) clearances under product code GPW
ApplicantClearances
Electro-Nucleonics Laboratories, Inc.1
Hillcrest Biologicals1
Institute Virion, Ltd.1
Sita, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code