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FDA 510(k)

FLAME PHOTOMETER MOLEL 4600, KDA

K-Number: K770824 · 1977-07-15

ApplicantAmerican Monitor Corp.
Decision Date1977-07-15
Product CodeJIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FLAME PHOTOMETER MOLEL 4600, KDA 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 1977-07-15 under 510(k) number K770824. The device is classified under product code JIH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLAME PHOTOMETER MOLEL 4600, KDA?

FLAME PHOTOMETER MOLEL 4600, KDA is a medical device that received FDA 510(k) clearance on 1977-07-15. The listed applicant is American Monitor Corp.. The 510(k) number is K770824.

When did FLAME PHOTOMETER MOLEL 4600, KDA receive FDA 510(k) clearance?

FLAME PHOTOMETER MOLEL 4600, KDA received FDA 510(k) clearance on 1977-07-15, under 510(k) number K770824.

Who is the listed applicant for FLAME PHOTOMETER MOLEL 4600, KDA?

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 FLAME PHOTOMETER MOLEL 4600, KDA?

The FDA product code for FLAME PHOTOMETER MOLEL 4600, KDA is JIH.

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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: JIH)

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.

K050338MODIFICATION TO: INSTAREAD LITHIUM SYSTEMAkers Biosciences, Inc.K031579INSTAREAD LITHIUM SYSTEMAkers Laboratories, Inc.K011033DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132Dade Behring, Inc.K934106KODAK EKTACHEM DTSC II SLIDES (LI)Eastman Kodak CompanyK924488KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)Eastman Kodak CompanyK921403MODEL 654 ANALYZERCiba Corning Diagnostics 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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