HERPES EIA TEST KIT— 510(k) K791397

Substantially Equivalent

Microbiological Assoc.

FDA 510(k) clearance K791397 for HERPES EIA TEST KIT, Substantially Equivalent on 1979-09-24. Applicant: Microbiological Assoc.. Device class: 2.

Clearance details

Applicant: Microbiological Assoc.
Product code: Code GQM
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 1979-07-27
Decision date: 1979-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQM

K875367 — COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV1988-03-28
K810043 — GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I1981-05-15

More clearances from Microbiological Assoc.

K792133 — RUBELISA TEST KIT1980-01-11
K781549 — TOXELISA TEST KIT1978-12-07
K780996 — RUBELISA TEST KIT1978-11-22
K781392 — CYTOMEGILISH TEST KIT1978-10-24
K781143 — IMMUNOFLUORESCENCE TEST KIT1978-08-14

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