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510(k) K770810

VARICELLA-ZOSTER FA LABELED PRESERUM by Flow Laboratories, Inc. — Product Code GQX

K770810 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "VARICELLA-ZOSTER FA LABELED PRESERUM". The FDA issued a decision of Substantially Equivalent on May 20, 1977. The device falls under product code GQX (Antiserum, Cf, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. 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
Antiserum, Cf, Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
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 GQX

  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • K911301 — VZV IGM TEST (July 17, 1991)
  • K883427 — VIRGO(R) VZV-IGG ELISA (March 10, 1989)
  • K875358 — VZV TEST (March 31, 1988)
  • K863317 — ENZYGNOST ANTI-VZV IGG TEST (April 22, 1987)
  • K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (February 4, 1986)
  • K852930 — VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (November 12, 1985)
  • K842096 — GLB VARICELLA-ZOSTER VIRUS FLUORESCENT (January 7, 1985)
  • K841526 — ORTHO VARICELLA-ZOSTER VIRUS IDENT. (June 25, 1984)
  • K770806 — VARICELLA-ZOSTER FA LABELLED (8-321 RF) (May 20, 1977)

FDA data resources