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FDA 510(k)

MONITORX LASERX THEOPHYLLINE REAGENT SET

K-Number: K870277 · 1987-02-18

ApplicantAmerican Monitor Corp.
Decision Date1987-02-18
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MONITORX LASERX THEOPHYLLINE REAGENT SET 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 1987-02-18 under 510(k) number K870277. The device is classified under product code LGS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITORX LASERX THEOPHYLLINE REAGENT SET?

MONITORX LASERX THEOPHYLLINE REAGENT SET is a medical device that received FDA 510(k) clearance on 1987-02-18. The listed applicant is American Monitor Corp.. The 510(k) number is K870277.

When did MONITORX LASERX THEOPHYLLINE REAGENT SET receive FDA 510(k) clearance?

MONITORX LASERX THEOPHYLLINE REAGENT SET received FDA 510(k) clearance on 1987-02-18, under 510(k) number K870277.

Who is the listed applicant for MONITORX LASERX THEOPHYLLINE REAGENT SET?

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 MONITORX LASERX THEOPHYLLINE REAGENT SET?

The FDA product code for MONITORX LASERX THEOPHYLLINE REAGENT SET is LGS.

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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: LGS)

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.

K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.K953016AXSYM THEOPHYLLINE IIAbbott LaboratoriesK951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.K942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott Laboratories

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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