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510(k) K770801

MICROBIO. PROD. FLUORESCENT ANTIBODY by Pfizer Pharmaceuticals — Product Code GMY

K770801 is an FDA 510(k) premarket notification submitted by Pfizer Pharmaceuticals for the device "MICROBIO. PROD. FLUORESCENT ANTIBODY". The FDA issued a decision of Substantially Equivalent on May 25, 1977. The device falls under product code GMY (Antisera, Fluorescent, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Pfizer Pharmaceuticals has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1977
Date Received
May 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Escherichia Coli
Device Class
Class I
Regulation Number
866.3255
Review Panel
MI
Submission Type

Other clearances by Pfizer Pharmaceuticals

  • K885321 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (March 22, 1989)
  • K810427 — CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. (March 31, 1981)
  • K802408 — E-VAC BLOOD CULTURE SYSTEM (October 23, 1980)
  • K771605 — CREATINE KINASE ISOENZYME SUBSTRATE SET (September 15, 1977)
  • K770425 — NEEDLES, STERILE, AIRWAY (April 15, 1977)

Other clearances for product code GMY

  • K770833 — FLUORETEC-M (June 8, 1977)

FDA data resources