STANDARDIZE TGCL & TGCH— 510(k) K781376

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K781376 for STANDARDIZE TGCL & TGCH, Substantially Equivalent on 1978-09-14. Applicant: American Monitor Corp.. Device class: 1.

Clearance details

Applicant: American Monitor Corp.
Product code: Code JTX
Device class: Class 1
Regulation: 21 CFR 866.2900
Advisory panel: Microbiology
Date received: 1978-08-09
Decision date: 1978-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTX

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K897151 — ACUSON V328 AND C5432 TRANSDUCERS1990-07-03
K882637 — ACCU-CULSHURE TM1988-07-06
K791724 — BIO-BAG ENVIRONMENTAL CHAMBER (A & B)1979-10-17
K780159 — ANASWAB1978-02-13

More clearances from American Monitor Corp.

K895999 — PHOSPHORUS1990-01-11
K896000 — ASPARTATE AMINOTRANFERASE (AST)1990-01-11
K896001 — ALANINE AMINOTRANSFERASE (ALT)1989-11-13
K895423 — ACCESS CHEMISTRY ANALYZER1989-10-04
K893137 — EXCEL (TM) CHEMISTRY ANALYZER1989-08-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.