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510(k) K900571

AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) by American Research Products Co. — Product Code CIG

K900571 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
February 7, 1990
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 American Research Products Co.

  • K942984 — BUN REAGENT (March 1, 1995)
  • K901527 — BIURET (COLORMETRIC), TOTAL PROTEIN (July 19, 1990)
  • K901960 — IRON REAGENTS PRODUCT CODES 7725 AND 7726 (May 31, 1990)
  • K901964 — PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 (May 31, 1990)
  • K900827 — COLORIMETRIC CHLORIDE PRODUCT #4314125 (May 2, 1990)
  • K901702 — NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 (April 25, 1990)
  • K900667 — AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 (April 19, 1990)
  • K900666 — AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 (April 19, 1990)
  • K900394 — AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (April 11, 1990)
  • K900977 — AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 (April 11, 1990)

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