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510(k) K770811

ADENOVIRUS GROUP-FA LABELLED PRESERUM by Flow Laboratories, Inc. — Product Code GNY

K770811 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "ADENOVIRUS GROUP-FA LABELLED PRESERUM". The FDA issued a decision of Substantially Equivalent on May 20, 1977. The device falls under product code GNY (Antisera, Fluorescent, Adenovirus 1-33), a Class I device regulated under 21 CFR 866.3020. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1977
Date Received
May 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Adenovirus 1-33
Device Class
Class I
Regulation Number
866.3020
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 GNY

  • K922801 — RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY (January 6, 1993)
  • K885310 — MURINE MONOCLONAL ANTI-ADENOVIRUS IGG (February 16, 1989)
  • K770807 — ADENOVIRUS-GROUP FA LABELLED (8-651 RF) (May 20, 1977)

FDA data resources