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510(k) K961587

IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 by Diagnostic Chemicals , Ltd. — Product Code JMO

K961587 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals , Ltd. for the device "IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25". The FDA issued a decision of Substantially Equivalent on Aug 27, 1996. The device falls under product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Diagnostic Chemicals , Ltd. has 65 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 27, 1996
Date Received
Apr 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Ferrozine (Colorimetric) Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type
510(k) Exempt

Other clearances by Diagnostic Chemicals , Ltd.

  • K070383 — ENZYMATIC CREATININE ASSAY (265 SERIES) (Jun 22, 2007)
  • K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (Jan 19, 2007)
  • K060139 — CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 (Apr 28, 2006)
  • K060140 — CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 (Apr 24, 2006)
  • K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (Nov 10, 2005)
  • K051191 — DCL MICROALBUMIN ASSAY, MODEL 252-20 (Jul 5, 2005)
  • K042330 — ACETAMINOPHEN-SL ASSAY (Jan 7, 2005)
  • K042329 — SALICYLATE-SL ASSAY (Dec 27, 2004)
  • K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50… (Dec 27, 2004)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (Nov 23, 2004)

Other clearances for product code JMO

  • K113438 — ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT… (Jun 1, 2012)
  • K061464 — VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120… (Jun 15, 2006)
  • K052867 — VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (Dec 23, 2005)
  • K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (Jul 16, 2004)
  • K013102 — WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT… (Nov 13, 2001)
  • K012340 — BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (Oct 1, 2001)
  • K000781 — DIRECT TIBC KIT (May 2, 2000)
  • K994115 — TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (Jan 28, 2000)
  • K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (Jun 30, 1999)
  • K991244 — TOTAL IRON, MODELS FE 109-01, FE 109-02 (May 25, 1999)

FDA data resources

Source: FDA 510(k) database entry for K961587. Report a data issue: hello@regdatalab.com.