BLASTOMYCES YEAST ANTIGEN— 510(k) K760828

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K760828 for BLASTOMYCES YEAST ANTIGEN, Substantially Equivalent on 1976-11-01. Applicant: I M, Inc.. Device class: 1.

Clearance details

Applicant: I M, Inc.
Product code: Code JJJ
Device class: Class 1
Regulation: 21 CFR 862.2320
Advisory panel: Clinical Chemistry
Date received: 1976-10-13
Decision date: 1976-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJJ

K962762 — SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR1996-08-16
K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER1995-03-30
K920559 — ABBOTT VERTEX ANALYZER1992-03-19
K900087 — GENESYS 6000 GAMMA COUNTER1990-07-19
K896202 — MATRIX(TM)-961990-01-02

More clearances from I M, Inc.

K914600 — NEUROLOGICAL SPONGE1992-12-30
K892389 — BIOPSY KIT1989-07-17
K881363 — SYRINGE PREFILLED WITH WATER1988-06-23
K880753 — UMBILICAL CORD CLAMP1988-04-27
K872741 — NUTRIPUMP1987-10-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.