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510(k) K013420

CHEMWELL, ALSO KNOWN AS PROJECT 2900 by Awareness Technology, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2002
Date Received
October 15, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

Other clearances by Awareness Technology, Inc.

  • K171476 — SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) (February 27, 2018)
  • K010877 — CHEMWELL, MODEL 2900 (May 23, 2001)
  • 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)

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