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510(k) K872073

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

K872073 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052". The FDA issued a decision of Substantially Equivalent on September 11, 1987. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. American Monitor Corp. has at least 10 other 510(k) clearances on record.

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.

  • K895999 — PHOSPHORUS (January 11, 1990)
  • K896000 — ASPARTATE AMINOTRANFERASE (AST) (January 11, 1990)
  • K896001 — ALANINE AMINOTRANSFERASE (ALT) (November 13, 1989)
  • 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)

Other clearances for product code JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)

FDA data resources