510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GPTClass I

Antiserum, Cf, Psittacosis (Chlamydia Group)

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

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

Classification record

Product code
GPT
Device name
Antiserum, 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
1
Ingested recalls
0

Clearances, product code GPT

By decision year
1 clearance under product code GPT with a decision year between 1981 and 1981, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GPT by decision year
YearClearances
19811

Applicants with the most clearances

Product code GPT
Applicants holding the most 510(k) clearances under product code GPT
ApplicantClearances
Bartels Immunodiagnostic Supplies, 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 GPT.