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FDA 510(k)

PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)

K-Number: K890034 · 1989-02-03

ApplicantAmerican Monitor Corp.
Decision Date1989-02-03
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) 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 1989-02-03 under 510(k) number K890034. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)?

PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is American Monitor Corp.. The 510(k) number is K890034.

When did PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) receive FDA 510(k) clearance?

PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) received FDA 510(k) clearance on 1989-02-03, under 510(k) number K890034.

Who is the listed applicant for PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)?

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 PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)?

The FDA product code for PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) is JIY.

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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: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K051115SENTINEL IRON LIQUIDSentinel Ch. SrlK033983VITALAB IRON REAGENTClinical Data, Inc.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.

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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