MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM— 510(k) K950073

Name: FDA 510(k) clearance K950073
Creator: U.S. Food and Drug Administration
Published: 1995-10-17

Substantially Equivalent

Shared Systems, Inc.

FDA 510(k) clearance K950073 for MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM, Substantially Equivalent on 1995-10-17. Applicant: Shared Systems, Inc.. Device class: 1.

Clearance details

Applicant: Shared Systems, Inc.
Product code: Code GSA
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1995-01-09
Decision date: 1995-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GSA

view all

K910833 — COLOR VUE TM- MYCOPLASMA PNEUMONIAE1991-06-24
K905493 — MERISTAR-MP1991-01-30
K903958 — SEROFAST1990-12-21
K883083 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM1988-10-25
K862630 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM1986-09-03

More clearances from Shared Systems, Inc.

view all

K973457 — CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 8001998-01-02
K955042 — CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM1995-12-13
K953261 — CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM1995-08-15
K920212 — MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM1992-08-20

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