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510(k) K790997

ANTI-DNASE B REAGENT SYSTEM by Calbiochem-Behring Corp. — Product Code GTR

K790997 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "ANTI-DNASE B REAGENT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 24, 1979. The device falls under product code GTR (Antideoxyribonuclease, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3720. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1979
Date Received
May 29, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antideoxyribonuclease, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3720
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)

FDA data resources