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510(k) K800228

IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT by Clinical Sciences, Inc. — Product Code DBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1980
Date Received
February 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5120
Review Panel
IM
Submission Type

Other clearances by Clinical Sciences, Inc.

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  • K883871 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 (July 14, 1989)
  • K883870 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 (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 DBE

  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)
  • K800820 — AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY (April 24, 1980)
  • K790430 — MEDICA II-F-ASMA TEST KIT (April 23, 1979)
  • K771155 — ANTI-MITOCHONDRIAL (August 4, 1977)
  • K760156 — TEST, (IVDP) SMOOTHMUSCLE ANTIBODY (July 20, 1976)