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510(k) K770824

FLAME PHOTOMETER MOLEL 4600, KDA by American Monitor Corp. — Product Code JIH

K770824 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "FLAME PHOTOMETER MOLEL 4600, KDA". The FDA issued a decision of Substantially Equivalent on July 15, 1977. The device falls under product code JIH (Flame Photometry, Lithium), a Class II device regulated under 21 CFR 862.3560. American Monitor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1977
Date Received
May 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Lithium
Device Class
Class II
Regulation Number
862.3560
Review Panel
TX
Submission Type

Other clearances by American Monitor Corp.

  • K896000 — ASPARTATE AMINOTRANFERASE (AST) (January 11, 1990)
  • K895999 — PHOSPHORUS (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 JIH

  • K050338 — MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (March 4, 2005)
  • K031579 — INSTAREAD LITHIUM SYSTEM (December 19, 2003)
  • K011033 — DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (June 7, 2001)
  • K934106 — KODAK EKTACHEM DTSC II SLIDES (LI) (April 25, 1994)
  • K924488 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) (January 26, 1993)
  • K921403 — MODEL 654 ANALYZER (July 30, 1992)
  • K895465 — AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE (December 27, 1989)
  • K894328 — TDX(R) LITES(TM) LITHIUM (November 13, 1989)
  • K830636 — POTASSIUM DILUENT (April 5, 1983)
  • K800039 — LITHIUM DILUENT (1500 MM/E) (January 21, 1980)

FDA data resources