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510(k) K901537

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

K901537 is an FDA 510(k) premarket notification submitted by Pb Diagnostic Systems, Inc. for the device "MODIFIED OPUS PHENOBARBITAL TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 12, 1990. The device falls under product code LET (Fluorescent 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
June 12, 1990
Date Received
April 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent 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 LET

  • K865000 — IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS (February 6, 1987)
  • K842592 — AMES TDA PHENOBARBITAL TEST (August 17, 1984)
  • K830701 — STRATUS PHENOBARBITAL FLUOROMETRIC ENZ (May 13, 1983)
  • K821408 — PHENOBARBITAL FLUORESCENT IMMUNO (May 24, 1982)
  • K820188 — PHENOBARBITAL ASSAY (February 5, 1982)
  • K810994 — AMES TDA TM PHENOBARBITAL TEST (April 29, 1981)
  • K802255 — AMES TDA PHENOBARBITAL TEST (September 26, 1980)

FDA data resources