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510(k) K780276

INFLUENZA HI ANTISERUM A/TEXAS by Flow Laboratories, Inc. — Product Code GNS

K780276 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "INFLUENZA HI ANTISERUM A/TEXAS". The FDA issued a decision of Substantially Equivalent on February 28, 1978. The device falls under product code GNS (Antisera, Hai, 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
Antisera, Hai, 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 GNS

  • K780696 — GOAT ANTIINFLUENZA ANTISERA AUSSR (May 3, 1978)
  • K780697 — GOAT ANTI-INFLUENZA ANTISERA ATEXAS (May 3, 1978)
  • K780274 — INFLUENZA HI ANTISERUM (February 28, 1978)
  • K780273 — INFLUENZA HI PRESERUM (February 28, 1978)
  • K780277 — INFLUENZA HI PRESERUM A/TEXAS (February 28, 1978)
  • K780005 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780006 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780004 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)

FDA data resources