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510(k) K872073

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 by American Monitor Corp. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1987
Date Received
May 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by American Monitor Corp.

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  • K895423 — ACCESS CHEMISTRY ANALYZER (October 4, 1989)
  • K893137 — EXCEL (TM) CHEMISTRY ANALYZER (August 10, 1989)
  • K892331 — ENZYMATIC UREA NITROGEN REAGENT SET (June 20, 1989)
  • K893479 — CHOLESTEROL REAGENT SET (June 19, 1989)
  • K892002 — NEOCHROME(R) III GLUCOSE (June 12, 1989)
  • K890312 — GAMMA-GLUTAMYLTRANSFERASE (March 24, 1989)
  • K890034 — PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) (February 3, 1989)

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