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510(k) K823211

CK-UV REAGENT by Biorent Diagnostic, Inc. — Product Code JHS

K823211 is an FDA 510(k) premarket notification submitted by Biorent Diagnostic, Inc. for the device "CK-UV REAGENT". The FDA issued a decision of Substantially Equivalent on November 22, 1982. The device falls under product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Biorent Diagnostic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1982
Date Received
October 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Biorent Diagnostic, Inc.

  • K832747 — ALBUMIN REAGENT SET (October 14, 1983)
  • K823060 — HEMOGLOBIN REAGENT (November 22, 1982)
  • K822493 — OPTIMIZED UV-GOT REAGENT SET (September 21, 1982)
  • K822494 — OPTIMIZED UV-GPT REAGENT SET (September 21, 1982)
  • K822492 — OPTIMIZED UV-LDH REAGENT SET (September 17, 1982)
  • K820768 — COLORIMETRIC LDH REAGENT SET (April 14, 1982)
  • K820632 — COLORIMETRIC URIC ACID REAGENT SET (March 25, 1982)
  • K813555 — GLUCOSE ENZYME-COLOR REAGENT SET (January 18, 1982)
  • K813244 — UV URIC ACID DETERMINATION (December 8, 1981)
  • K811760 — CHOLESTEROL DETERMINATION (July 10, 1981)

Other clearances for product code JHS

  • K160570 — Creatine Kinase (May 25, 2016)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K082226 — S40 CREATINE KINASE (CK) (September 18, 2008)
  • K062128 — THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (August 21, 2006)
  • K990434 — CARESIDE CKMB (April 19, 1999)
  • K990439 — CARESIDE CK (April 19, 1999)
  • K981495 — IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) (June 10, 1998)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K952250 — STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIME (July 17, 1995)
  • K945083 — ACCESS CK-MB REAGENTS (November 21, 1994)

FDA data resources