Home / 510(k) Clearances / K971524

510(k) K971524

TOTAL PROTEIN OR TP by Carolina Liquid Chemistries Corp. — Product Code CEK

K971524 is an FDA 510(k) premarket notification submitted by Carolina Liquid Chemistries Corp. for the device "TOTAL PROTEIN OR TP". The FDA issued a decision of Substantially Equivalent on May 16, 1997. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Carolina Liquid Chemistries Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1997
Date Received
April 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biuret (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

Other clearances by Carolina Liquid Chemistries Corp.

  • K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (C (January 27, 2022)
  • K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMIS (May 16, 2014)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K971907 — CALCIUM REAGENT (June 24, 1997)
  • K972073 — TOTAL BILIRUBIN REAGENT (June 24, 1997)
  • K971324 — TRIGLYCERIDES, TG, OR TRIG (June 20, 1997)
  • K971967 — BUN (June 17, 1997)
  • K971908 — CREA OR CREATININE (June 17, 1997)
  • K971467 — SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) (June 16, 1997)
  • K971396 — CK REAGENT (May 29, 1997)

Other clearances for product code CEK

  • K992846 — HICHEM TOTAL PROTEIN REAGENT (October 18, 1999)
  • K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (March 2, 1998)
  • K980042 — CARESIDE TOTAL PROTEIN (February 4, 1998)
  • K961864 — CSF/URINE TOTAL PROTEIN (October 24, 1996)
  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 1996)
  • K955936 — TOTAL PROTEIN REAGENT (March 12, 1996)
  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (August 11, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K943004 — TOTAL PROTEIN QVET (December 9, 1994)

FDA data resources