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510(k) K820088

AFT SYSTEM PROFICIENCY TESTING PROGRAM by Calbiochem-Behring Corp. — Product Code DBL

K820088 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "AFT SYSTEM PROFICIENCY TESTING PROGRAM". The FDA issued a decision of Substantially Equivalent on January 26, 1982. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1982
Date Received
January 13, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
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)
  • K812458 — PADAC (September 23, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)
  • K810404 — RHEUMATOID FACTORS REFERENCE SERUM (March 11, 1981)

Other clearances for product code DBL

  • K180202 — Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immun (October 19, 2018)
  • K980312 — NOVA LITE ENDOMYSIAL (April 2, 1998)
  • K974169 — WIELISA ANTI-GBM TEST SYSTEM (February 17, 1998)
  • K971464 — IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (October 29, 1997)
  • K971658 — MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (May 23, 1997)
  • K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (November 7, 1996)
  • K955431 — RIT LIVER, KIDNEY, STOMACH IFA KIT (April 23, 1996)
  • K953495 — EIA KIT FOR THE DETECTION OF GBM ANTIBODIES (April 10, 1996)
  • K944192 — ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER (March 6, 1995)
  • K944191 — ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER (March 6, 1995)

FDA data resources