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510(k) K895964

DCL SYPHILIS-M CATALOG NO. 600-80 by Diagnostic Chemicals, Ltd. (Usa) — Product Code LIP

K895964 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals, Ltd. (Usa) for the device "DCL SYPHILIS-M CATALOG NO. 600-80". The FDA issued a decision of Substantially Equivalent on January 8, 1991. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Diagnostic Chemicals, Ltd. (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1991
Date Received
October 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Diagnostic Chemicals, Ltd. (Usa)

  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K974874 — BILIRUBIN-SL (TOTAL) ASSAY (February 12, 1998)
  • K932556 — AMMONIA ASSAY CAT. NO. 200-02 (August 2, 1994)
  • K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) (December 10, 1993)
  • K932555 — DC-LINEATE CAT. NO. SE-091 (August 19, 1993)
  • K925877 — DC-UIBC-CAL (March 18, 1993)
  • K912825 — MAGNESIUM ASSAY KIT, CAT.# 100-12 (July 26, 1991)
  • K895965 — DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (December 26, 1990)
  • K904660 — ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (November 20, 1990)
  • K901510 — ENZYMATIC THEOPHYLLINE REAGENT, #500-82 (June 12, 1990)

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  • K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator (May 11, 2017)
  • K160910 — Elecsys Syphilis (July 28, 2016)
  • K153145 — Lumipulse G TP-N Immunoreaction Cartridge Set (July 5, 2016)
  • K153730 — ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphi (June 15, 2016)
  • K120439 — BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (March 14, 2012)
  • K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (January 20, 2012)
  • K102400 — SYPHILIS HEALTH CHECK (August 1, 2011)

FDA data resources