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510(k) K813038

ULTRACHEM TP, ITEM #64974 by Harleco — Product Code CEK

K813038 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRACHEM TP, ITEM #64974". The FDA issued a decision of Substantially Equivalent on November 10, 1981. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Harleco has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1981
Date Received
October 28, 1981
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 Harleco

  • K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056) (February 12, 1982)
  • K813427 — ULTRACHEM GLUC-DH (December 31, 1981)
  • K813039 — ULTRACHEM E-CHOL, ITEM #65025 (November 10, 1981)
  • K813043 — ULTRACHEM CREA ITEM #64972 (November 10, 1981)
  • K813044 — ULTRACHEM ALB, ITEM #64970 (November 10, 1981)
  • K813041 — ULTRAZYME-GT, ITEM #64959 & 65032 (November 10, 1981)
  • K813042 — ULTRACHEM GLUC-DH SET, ITEM #65048 (November 10, 1981)
  • K813040 — ULTRACHEM CA, ITEM #64975 (November 10, 1981)
  • K812594 — ULTRA ZYME PLUS AMYL #64982 & 65031 (October 2, 1981)
  • K812593 — ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 (October 2, 1981)

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)
  • K971524 — TOTAL PROTEIN OR TP (May 16, 1997)
  • 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)

FDA data resources