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510(k) K852767

ERYTHOCYTE CREATINE by Panmed, Inc. — Product Code JLA

K852767 is an FDA 510(k) premarket notification submitted by Panmed, Inc. for the device "ERYTHOCYTE CREATINE". The FDA issued a decision of Substantially Equivalent on November 13, 1986. The device falls under product code JLA (Conversion To Creatinine, Creatine), a Class I device regulated under 21 CFR 862.1210. Panmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1986
Date Received
June 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conversion To Creatinine, Creatine
Device Class
Class I
Regulation Number
862.1210
Review Panel
CH
Submission Type

Other clearances by Panmed, Inc.

  • K820642 — SICKLE-CHECK (April 14, 1982)
  • K802157 — BCG REAGENT SERUM ALBUMIN W/TECHNICON (October 10, 1980)
  • K802161 — BIURET REAGENT & TOTAL PROTEIN BLANK SOL (October 10, 1980)
  • K802158 — POSTASSIUM BUFFER SOL. & WASH SOLUTION (October 10, 1980)
  • K802163 — CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT (October 10, 1980)
  • K802155 — REAGENTS SERUM SODIUM USING THE TECH. (October 10, 1980)
  • K802160 — BUN COLOR REAGENT & BUN ACID USED (October 10, 1980)
  • K802154 — REAGENTS USED-QUAN. MEASURE OF SERUM (October 10, 1980)
  • K802156 — REAGENTS SERUM CREATINE USING TECHICON (October 10, 1980)
  • K802164 — 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. (October 10, 1980)

Other clearances for product code JLA

  • K854016 — ASSERACHROM PROTEIN C KIT (January 3, 1986)

FDA data resources