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510(k) K850158

CHLAMYDIA FLUORO-KIT 1680 by Clinical Sciences, Inc. — Product Code LJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1985
Date Received
January 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

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  • 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 LJP

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  • K901243 — CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST (May 21, 1990)
  • K900870 — PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST (April 16, 1990)
  • K895839 — PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 (February 1, 1990)
  • K883352 — FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (October 6, 1988)
  • K881500 — ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST (April 27, 1988)
  • K880031 — PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS (March 17, 1988)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
  • K872903 — MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. (August 6, 1987)