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510(k) K771955

TRYPSIN 1% by Flow Laboratories, Inc. — Product Code IBG

K771955 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "TRYPSIN 1%". The FDA issued a decision of Substantially Equivalent on November 22, 1977. The device falls under product code IBG (Trypsin), a Class I device regulated under 21 CFR 864.4400. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
October 17, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trypsin
Device Class
Class I
Regulation Number
864.4400
Review Panel
PA
Submission Type

Other clearances by Flow Laboratories, Inc.

  • K861897 — UNISKAN II (July 1, 1986)
  • K862066 — TITERTEK MICROPLATE WASHER S-12 (June 5, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG 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)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)

Other clearances for product code IBG

  • K802493 — SPUTASOL (November 12, 1980)

FDA data resources