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510(k) K780275

INFLUENZA HA ANTIGEN A/USSR by Flow Laboratories, Inc. — Product Code GNT

K780275 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "INFLUENZA HA ANTIGEN A/USSR". The FDA issued a decision of Substantially Equivalent on February 28, 1978. The device falls under product code GNT (Antigens, Ha (Including Ha Control), Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1978
Date Received
February 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

Other clearances by Flow Laboratories, Inc.

  • K861897 — UNISKAN II (July 1, 1986)
  • K862066 — TITERTEK MICROPLATE WASHER S-12 (June 5, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K860752 — GOAT SERUM (29-391-54) (March 10, 1986)
  • K860762 — GAMMA-FREE HORSE SERUM (March 10, 1986)
  • K850908 — TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (March 25, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)

Other clearances for product code GNT

  • K950838 — VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES (June 17, 1996)
  • K913828 — QTEST INFLUENZA A (September 23, 1991)
  • K902609 — DIRECTIGEN FLU A (September 10, 1990)
  • K780272 — INFLUENZA HA ANTIGEN (February 28, 1978)

FDA data resources