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FDA 510(k)

ETHANOL CALIBRATOR

K-Number: K872181 · 1987-07-21

ApplicantAmerican Monitor Corp.
Decision Date1987-07-21
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHANOL CALIBRATOR 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 1987-07-21 under 510(k) number K872181. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHANOL CALIBRATOR?

ETHANOL CALIBRATOR is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is American Monitor Corp.. The 510(k) number is K872181.

When did ETHANOL CALIBRATOR receive FDA 510(k) clearance?

ETHANOL CALIBRATOR received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872181.

Who is the listed applicant for ETHANOL CALIBRATOR?

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 ETHANOL CALIBRATOR?

The FDA product code for ETHANOL CALIBRATOR is DLJ.

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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: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, 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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