Home / 510(k) Clearances / K131051

510(k) K131051

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) by Hitachi Chemical Diagnostics, Inc. — Product Code JGQ

K131051 is an FDA 510(k) premarket notification submitted by Hitachi Chemical Diagnostics, Inc. for the device "HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)". The FDA issued a decision of Substantially Equivalent on June 7, 2013. The device falls under product code JGQ (Turbidimetric, Total Protein), a Class II device regulated under 21 CFR 862.1635. Hitachi Chemical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2013
Date Received
April 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric, Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

Other clearances by Hitachi Chemical Diagnostics, Inc.

  • K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle (October 18, 2021)
  • K182793 — AP3600 Automated Instrument (March 19, 2019)
  • K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (March 11, 2014)
  • K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (October 28, 2013)
  • K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (August 9, 2013)
  • K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (June 7, 2013)
  • K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZE (June 7, 2013)
  • K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (May 2, 2013)
  • K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (March 22, 2013)
  • K112910 — AP 72OS SEMI-AUTOMATED INSTRUMENT (December 20, 2012)

Other clearances for product code JGQ

  • K072638 — ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (October 19, 2007)
  • K071239 — TOTAL PROTEIN URINE/CSF GEN.3 (September 14, 2007)
  • K981295 — UPRO (October 1, 1998)
  • K981682 — UPRO (September 21, 1998)
  • K925794 — TRACE MICROPROTEIN REAGENT (March 29, 1993)
  • K913615 — URINARY/CSF PROTEIN (September 13, 1991)
  • K903914 — PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK (October 3, 1990)
  • K901083 — EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 (April 16, 1990)
  • K863478 — CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (October 29, 1986)
  • K842134 — SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (July 6, 1984)

FDA data resources