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510(k) K832675

ANA MICROZYME TEST SYS #1610 by Clinical Sciences, Inc. — Product Code DAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
August 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
PA
Submission Type

Other clearances by Clinical Sciences, Inc.

  • K900688 — VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT (May 15, 1990)
  • K883870 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 (July 14, 1989)
  • K883871 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 (July 14, 1989)
  • K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 (June 15, 1989)
  • K883601 — EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 (May 11, 1989)
  • K883600 — EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 (May 11, 1989)
  • K874594 — TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 (March 7, 1988)
  • K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (January 11, 1988)
  • K860145 — RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 (July 14, 1986)
  • K860773 — TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 (May 23, 1986)

Other clearances for product code DAA

  • K831927 — ANTINUCLEAR ANTIBODY TEST KIT (July 18, 1983)
  • K830005 — IP SPECIFIC G (June 2, 1983)
  • K822911 — ANAZYME ANA PEROXIDASE TEST SYSTEM (October 22, 1982)
  • K791749 — INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL (October 17, 1979)