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510(k) K820308

ANA-DISC SYSTEM by Flow Laboratories, Inc. — Product Code KZJ

K820308 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "ANA-DISC SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 1982. The device falls under product code KZJ (Device, Gas Generating), a Class I device regulated under 21 CFR 866.2580. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1982
Date Received
February 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Gas Generating
Device Class
Class I
Regulation Number
866.2580
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)
  • 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)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)

Other clearances for product code KZJ

  • K881502 — BREWER GEL FOR CAMPYLOBACTER (April 27, 1988)
  • K875362 — BREWER GEL FOR ANAEROBES (January 27, 1988)
  • K872782 — BBL(R) GASPAK CO2 POUCH(TM) (August 6, 1987)
  • K871709 — ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) (May 15, 1987)
  • K871238 — ANABAG (April 3, 1987)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)
  • K853534 — BBL CAMPY POUCH (August 29, 1985)
  • K845008 — BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE (March 5, 1985)
  • K844571 — CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE (January 30, 1985)
  • K841117 — GASPAK PLUS DISPOS. HYDROGEN & (April 4, 1984)

FDA data resources