Home / 510(k) Clearances / K790460

510(k) K790460

TXOCELL-IHA REAGENT SYSTEM by Calbiochem-Behring Corp. — Product Code GMM

K790460 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "TXOCELL-IHA REAGENT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 25, 1979. The device falls under product code GMM (Antigens, Iha, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1979
Date Received
March 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Iha, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Calbiochem-Behring Corp.

  • K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE (July 28, 1983)
  • K831036 — ENA TEST KIT SM & RNP AUTO ANTIBODY (April 27, 1983)
  • K830214 — AFT SYSTEM III (March 9, 1983)
  • K820812 — CREATINE KINASE-MB KIT (April 12, 1982)
  • K813493 — ENZYGNOST TM RUBELLA IGM (March 4, 1982)
  • K820088 — AFT SYSTEM PROFICIENCY TESTING PROGRAM (January 26, 1982)
  • K812458 — PADAC (September 23, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)

Other clearances for product code GMM

  • K981263 — TOXOGEN (August 6, 1998)
  • K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (November 20, 1995)
  • K851976 — HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT (October 16, 1985)
  • K851977 — HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT (October 16, 1985)
  • K830870 — POLYCHACO INDIRECT HEMAGGLUTINATION (August 12, 1983)
  • K802452 — TOXOTEST-MT EIKEN KIT (December 18, 1980)
  • K771560 — TOXHA TEST (September 15, 1977)

FDA data resources