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

Trypsin

21 CFR 864.4400 / Pathology
FDA source (opens on fda.gov)

IBG is the FDA product code for Trypsin, a class I device type, regulated under 21 CFR 864.4400. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IBG
Device name
Trypsin
Regulation
21 CFR 864.4400
Device class
Class I
Review panel
Pathology
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
1

Clearances, product code IBG

By decision year
2 clearances under product code IBG with a decision year between 1977 and 1980, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IBG by decision year
YearClearances
19771
19801

Applicants with the most clearances

Product code IBG
Applicants holding the most 510(k) clearances under product code IBG
ApplicantClearances
Flow Laboratories, Inc.1
Oxoid U.S.A., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code