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510(k) K913190

EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS by Syva Co. — Product Code DLZ

K913190 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS". The FDA issued a decision of Substantially Equivalent on August 26, 1991. The device falls under product code DLZ (Enzyme Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
July 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
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)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (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 DLZ

  • K210858 — VITROS Chemistry Products PHBR Slides (August 13, 2021)
  • K123271 — ABBOTT PHENOBARBITAL ASSAY (April 26, 2013)
  • K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODE (September 26, 2008)
  • K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 (September 12, 2007)
  • K011303 — RANDOX PHENOBARBITAL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K000012 — IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 (March 3, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)
  • K984288 — VITROS CHEMISTRY PRODUCTS PHBR SLIDES (January 26, 1999)
  • K946210 — PHENOBARBITAL ENZYME IMMUNOASSAY (February 10, 1995)

FDA data resources