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510(k) K810309

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

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

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  • K813493 — ENZYGNOST TM RUBELLA IGM (March 4, 1982)
  • K820088 — AFT SYSTEM PROFICIENCY TESTING PROGRAM (January 26, 1982)
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  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K810404 — RHEUMATOID FACTORS REFERENCE SERUM (March 11, 1981)

Other clearances for product code GOL

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  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)
  • K802339 — EIA RUBELLA-G (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)