Home / 510(k) Clearances / K810309

510(k) K810309

RUBELLA ANTIBODIES TEST REAGENTS by Calbiochem-Behring Corp. — Product Code GOL

K810309 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "RUBELLA ANTIBODIES TEST REAGENTS". The FDA issued a decision of Substantially Equivalent on March 11, 1981. The device falls under product code GOL (Antigen, Ha (Including Ha Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1981
Date Received
February 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ha (Including Ha Control), Rubella
Device Class
Class II
Regulation Number
866.3510
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)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)
  • K810404 — RHEUMATOID FACTORS REFERENCE SERUM (March 11, 1981)

Other clearances for product code GOL

  • K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAY (June 7, 1984)
  • K834032 — RUBAQUICK DIAGNOSTIC KIT (April 17, 1984)
  • K802339 — EIA RUBELLA-G (December 18, 1980)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)
  • K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (December 18, 1980)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)
  • K801098 — ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (September 16, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)
  • K800797 — MACRO-VUE RUBELLA CARD TEST (June 20, 1980)

FDA data resources