Home / 510(k) Clearances / K770216

510(k) K770216

VIRAL ANTISERA, FLUORESCEIN LABELED by Flow Laboratories, Inc. — Product Code GRA

K770216 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "VIRAL ANTISERA, FLUORESCEIN LABELED". The FDA issued a decision of Substantially Equivalent on March 1, 1977. The device falls under product code GRA (Antiserum, Fluorescent, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1977
Date Received
February 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
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 GRA

  • K894624 — MUMPS VIRUS (October 16, 1989)
  • K822826 — ANTIBODY TO MUMPS VIRUS IFA TEST (December 3, 1982)

FDA data resources