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510(k) K781376

STANDARDIZE TGCL & TGCH by American Monitor Corp. — Product Code JTX

K781376 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "STANDARDIZE TGCL & TGCH". The FDA issued a decision of Substantially Equivalent on September 14, 1978. The device falls under product code JTX (Transport Systems, Anaerobic), a Class I device regulated under 21 CFR 866.2900. American Monitor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1978
Date Received
August 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport Systems, Anaerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
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 JTX

  • K901645 — ANAEROBIC ACCU-CULSHURE(TM) (July 16, 1990)
  • K897151 — ACUSON V328 AND C5432 TRANSDUCERS (July 3, 1990)
  • K882637 — ACCU-CULSHURE TM (July 6, 1988)
  • K791724 — BIO-BAG ENVIRONMENTAL CHAMBER (A & B) (October 17, 1979)
  • K780159 — ANASWAB (February 13, 1978)
  • K761241 — PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE (December 30, 1976)
  • K760063 — SPECIMEN COLLECTOR, ANAEROBIC (August 3, 1976)

FDA data resources