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FDA 510(k)

TPTZ CHLORIDE

K-Number: K820235 · 1982-02-12

ApplicantAmerican Monitor Corp.
Decision Date1982-02-12
Product CodeCHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TPTZ CHLORIDE 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 1982-02-12 under 510(k) number K820235. The device is classified under product code CHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TPTZ CHLORIDE?

TPTZ CHLORIDE is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is American Monitor Corp.. The 510(k) number is K820235.

When did TPTZ CHLORIDE receive FDA 510(k) clearance?

TPTZ CHLORIDE received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820235.

Who is the listed applicant for TPTZ CHLORIDE?

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 TPTZ CHLORIDE?

The FDA product code for TPTZ CHLORIDE is CHJ.

Related Clinical Trials

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.

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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

View all 73 devices →

Related Devices (Code: CHJ)

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.

K010670PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERCatachem, Inc.K943006CHLORIDE QVETPrisma SystemsK934136OLYMPUS CHLORIDE REAGENT, MODIFICATIONOlympus Corp.K932528OLYMPUS CHLORID REAGENT, MODIFIEDOlympus Corp.K925338OLYMPUS CHLORIDE REAGENTOlympus Corp.

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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