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510(k) K010877

CHEMWELL, MODEL 2900 by Awareness Technology, Inc. — Product Code CIX

K010877 is an FDA 510(k) premarket notification submitted by Awareness Technology, Inc. for the device "CHEMWELL, MODEL 2900". The FDA issued a decision of Substantially Equivalent on May 23, 2001. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Awareness Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2001
Date Received
March 23, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Awareness Technology, Inc.

  • K171476 — SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) (February 27, 2018)
  • K013420 — CHEMWELL, ALSO KNOWN AS PROJECT 2900 (July 19, 2002)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K943729 — DYE CHECK STRIPS 545-630 (December 29, 1994)
  • K941394 — STAT FAX 2600 (June 3, 1994)
  • K923598 — REDI-CHECK PHOTMETER Q.A. (October 14, 1992)
  • K900224 — STAT FAX(TM)-2100 (March 1, 1990)
  • K892656 — DRI-DYE CHECK STRIPS (TM)-405 (May 22, 1989)
  • K882938 — STAT FAX(TM) (September 9, 1988)
  • K873451 — PROJECT 300 MICROASSAY BP-12, EIA MINILAB (November 4, 1987)

Other clearances for product code CIX

  • K251157 — Core Metabolic (January 9, 2026)
  • K203248 — Albumin BCG2 (November 23, 2021)
  • K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medic (September 21, 2021)
  • K191316 — VITROS XT Chemistry Products ALB-TP Slides (June 7, 2019)
  • K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 (April 13, 2018)
  • K131488 — ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND (August 19, 2013)
  • K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE P (July 13, 2012)
  • K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEI (September 8, 2011)
  • K110830 — ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELI (June 21, 2011)
  • K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (April 4, 2011)

FDA data resources