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510(k) K896861

OPUS PHENOBARBITAL TEST SYSTEM by Pb Diagnostic Systems, Inc. — Product Code DLZ

K896861 is an FDA 510(k) premarket notification submitted by Pb Diagnostic Systems, Inc. for the device "OPUS PHENOBARBITAL TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on January 11, 1990. The device falls under product code DLZ (Enzyme Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Pb Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
December 5, 1989
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 Pb Diagnostic Systems, Inc.

  • K940507 — OPUS FT4 TEST SYSTEM (July 28, 1994)
  • K934762 — OPUS PROCAINAMIDE TEST SYSTEM (July 20, 1994)
  • K933389 — OPUS CMV-G (June 28, 1994)
  • K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION (March 7, 1994)
  • K935229 — OPUS DIGITOXIN (December 22, 1993)
  • K934705 — OPUS NAPA (November 22, 1993)
  • K933675 — OPUS TOTAL CK (September 8, 1993)
  • K933066 — OPUS ESTRADIOL (September 8, 1993)
  • K932279 — OPUS(R) TOTAL B-HCG TEST SYSTEM (July 8, 1993)
  • K926131 — OPUS MAGNUM ANALYZER (June 7, 1993)

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