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FDA 510(k)

STANDARDIZE TGCL & TGCH

K-Number: K781376 · 1978-09-14

ApplicantAmerican Monitor Corp.
Decision Date1978-09-14
Product CodeJTX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STANDARDIZE TGCL & TGCH is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1978-09-14 under 510(k) number K781376. The device is classified under product code JTX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDARDIZE TGCL & TGCH?

STANDARDIZE TGCL & TGCH is a medical device that received FDA 510(k) clearance on 1978-09-14. The listed applicant is American Monitor Corp.. The 510(k) number is K781376.

When did STANDARDIZE TGCL & TGCH receive FDA 510(k) clearance?

STANDARDIZE TGCL & TGCH received FDA 510(k) clearance on 1978-09-14, under 510(k) number K781376.

Who is the listed applicant for STANDARDIZE TGCL & TGCH?

The FDA 510(k) record lists American Monitor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANDARDIZE TGCL & TGCH?

The FDA product code for STANDARDIZE TGCL & TGCH is JTX.

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Other records listing American Monitor Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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Related Devices (Code: JTX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K901645ANAEROBIC ACCU-CULSHURE(TM)Medical Laboratory Automation Systems, Inc.K897151ACUSON V328 AND C5432 TRANSDUCERSAcuson Corp.K882637ACCU-CULSHURE TMAccu-Med Corp.K791724BIO-BAG ENVIRONMENTAL CHAMBER (A & B)Marion Laboratories, Inc.K780159ANASWABScott Laboratories, Inc.K761241PRE-DUCED SURGI-SWAB & TRANSPORTER TUBEGibco Laboratories Life Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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