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510(k) K802154

REAGENTS USED-QUAN. MEASURE OF SERUM by Panmed, Inc. — Product Code CIG

K802154 is an FDA 510(k) premarket notification submitted by Panmed, Inc. for the device "REAGENTS USED-QUAN. MEASURE OF SERUM". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Panmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
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)
  • K802158 — POSTASSIUM BUFFER SOL. & WASH SOLUTION (October 10, 1980)
  • K802157 — BCG REAGENT SERUM ALBUMIN W/TECHNICON (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)
  • K802156 — REAGENTS SERUM CREATINE USING TECHICON (October 10, 1980)
  • K802164 — 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. (October 10, 1980)

Other clearances for product code CIG

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (February 27, 2026)
  • K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil) (June 12, 2023)
  • K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil) (March 20, 2023)
  • K223324 — Total Bilirubin2 (December 29, 2022)
  • K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides (April 26, 2019)
  • K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN (July 11, 2017)
  • K150510 — Total Bilirubin (April 2, 2015)
  • K131544 — COBAS C BILIRUBIN TOTAL GEN.3 (July 17, 2013)
  • K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (June 7, 2013)
  • K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (March 1, 2013)

FDA data resources