Home / 510(k) Clearances / K792637

510(k) K792637

CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) by Union Carbide Corp. — Product Code KTS

K792637 is an FDA 510(k) premarket notification submitted by Union Carbide Corp. for the device "CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)". The FDA issued a decision of Substantially Equivalent on January 11, 1980. The device falls under product code KTS (Second Antibody (Species Specific Anti-Animal Gamma Globulin)), a Class II device regulated under 21 CFR 866.5510. Union Carbide Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1980
Date Received
December 20, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Union Carbide Corp.

  • K830337 — MARK III OXYGEN WALKER SYS-LOW PRESS (March 17, 1983)
  • K820836 — MARK III OXYGEN WALKER SYSTEM (April 15, 1982)
  • K820535 — LASER GAS MIXTURES (March 31, 1982)
  • K812536 — LINDE MARK II (September 23, 1981)
  • K810732 — LINDE MARK II OXYGEN RESERV. TYPE OR-4 (March 27, 1981)
  • K810596 — CENTRIFI CHEM SYSTEM 400 ANALYZER (March 17, 1981)
  • K810129 — CENTRIFICHEM SYSTEM 500 (February 2, 1981)
  • K803216 — CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT (January 9, 1981)
  • K802741 — CENTRIFICHEM COMB. SERUM-BASED CALIB. (December 10, 1980)
  • K802520 — CENTRIFICHEM PIPETTOR ACCURACY CALIB. (November 12, 1980)

Other clearances for product code KTS

  • K813508 — SAC-CEL (December 29, 1981)
  • K792636 — CENTRIA RADIOIMMUNOASSAY SEPARATION (January 11, 1980)
  • K781070 — SECOND ANTIBODY (August 10, 1978)

FDA data resources