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510(k) K894159

OPUS IMMUNOASSAY SYSTEM by Pb Diagnostic Systems, Inc. — Product Code KHO

K894159 is an FDA 510(k) premarket notification submitted by Pb Diagnostic Systems, Inc. for the device "OPUS IMMUNOASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code KHO (Fluorometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2560. Pb Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
June 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
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 KHO

  • K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, (January 20, 2012)
  • K973547 — TRIAGE STATMETER (January 13, 1998)
  • K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (June 27, 1997)
  • K962919 — VITROS IMMUNODIAGNOSTIC SYSTEM (October 18, 1996)
  • K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (November 22, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K935047 — AUTO DELFIA (May 23, 1994)
  • K930689 — AUTOBEAD THYROID UPTAKE (November 10, 1993)
  • K926131 — OPUS MAGNUM ANALYZER (June 7, 1993)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)

FDA data resources