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510(k) K780542

ALFATEST by Panmed, Inc. — Product Code LBR

K780542 is an FDA 510(k) premarket notification submitted by Panmed, Inc. for the device "ALFATEST". The FDA issued a decision of Substantially Equivalent on May 19, 1978. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Panmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1978
Date Received
April 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Panmed, Inc.

  • K852767 — ERYTHOCYTE CREATINE (November 13, 1986)
  • K820642 — SICKLE-CHECK (April 14, 1982)
  • K802161 — BIURET REAGENT & TOTAL PROTEIN BLANK SOL (October 10, 1980)
  • K802160 — BUN COLOR REAGENT & BUN ACID USED (October 10, 1980)
  • K802157 — BCG REAGENT SERUM ALBUMIN W/TECHNICON (October 10, 1980)
  • K802155 — REAGENTS SERUM SODIUM USING THE TECH. (October 10, 1980)
  • K802158 — POSTASSIUM BUFFER SOL. & WASH SOLUTION (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 LBR

  • K143691 — LDLC3 LDL-Cholesterol Gen.3 (January 28, 2015)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (January 22, 2008)
  • K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (July 26, 2005)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRO (August 30, 2001)
  • K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (August 12, 1999)
  • K992002 — AUTOHDL CHOLESTEROL REAGENT SET (August 5, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (July 9, 1999)
  • K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (May 28, 1999)
  • K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (January 28, 1999)

FDA data resources