MYCOPLASMA PNEUMONIAE— 510(k) K843664

Substantially Equivalent

Institute Virion , Ltd.

FDA 510(k) clearance K843664 for MYCOPLASMA PNEUMONIAE, Substantially Equivalent on 1984-10-25. Applicant: Institute Virion , Ltd.. Device class: 1.

Clearance details

Applicant: Institute Virion , Ltd.
Product code: Code GSB
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1984-09-17
Decision date: 1984-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GSB

K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS1985-08-01
K834338 — MYCOPLASMA PNEUMONIAE CF ANTIGEN1984-02-27
K832132 — SERA-TEK MYCOPLASMA ANTIBODY TEST1983-09-20
K802934 — MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL1980-12-31

More clearances from Institute Virion , Ltd.

K862814 — COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI1986-09-30
K843649 — ADENOVIRUS1985-09-26
K843657 — CYTOMEGALOVIRUS1985-09-26
K843658 — H. SIMPLEX VIRUS1985-09-26
K843659 — INFLUENZA A2 VIRUS1985-09-26

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