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510(k) K924957

OPUS(R) VANCOMYCIN by Pb Diagnostic Systems, Inc. — Product Code LEH

K924957 is an FDA 510(k) premarket notification submitted by Pb Diagnostic Systems, Inc. for the device "OPUS(R) VANCOMYCIN". The FDA issued a decision of Substantially Equivalent on December 11, 1992. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Pb Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1992
Date Received
September 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Vancomycin
Device Class
Class II
Regulation Number
862.3950
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 LEH

  • K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (August 8, 2023)
  • K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (April 27, 2016)
  • K152245 — ONLINE TDM Vancomycin Gen.3 (January 8, 2016)
  • K123947 — ARCHITECT IVANCOMYCIN (August 29, 2013)
  • K072036 — ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P (March 19, 2008)
  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K060586 — ENZYME IMMUNOASSAY, VANCOMYCIN (May 11, 2006)
  • K050419 — QMS VANCOMYCIN (April 1, 2005)
  • K043386 — VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VE (February 7, 2005)
  • K032811 — CEDIA VANCOMYCIN ASSAY (November 24, 2003)

FDA data resources