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510(k) K921462

MICROTRAK(R) II CHLAMYDIA EIA ASSAY by Syva Co. — Product Code LJC

K921462 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "MICROTRAK(R) II CHLAMYDIA EIA ASSAY". The FDA issued a decision of Substantially Equivalent on September 25, 1992. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1992
Date Received
March 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Syva Co.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)

Other clearances for product code LJC

  • K032330 — CT OIA (March 2, 2004)
  • K033865 — IDEIA PCE CHLAMYDIA (January 21, 2004)
  • K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM (November 26, 2003)
  • K982210 — MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (July 9, 1998)
  • K962558 — CHLAMYDIA IGG ELISA TEST SYSTEM (February 24, 1997)
  • K960850 — ACCESS CHLAMYDIA ASSAY (February 4, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K936054 — IMX SELECT CHLAMYDIA (May 30, 1996)
  • K940564 — IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (January 11, 1996)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)

FDA data resources