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FDA 510(k)

PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT

K-Number: K923569 · 1992-08-26

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-08-26
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-08-26 under 510(k) number K923569. The device is classified under product code JMO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT?

PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT is a medical device that received FDA 510(k) clearance on 1992-08-26. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K923569.

When did PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT receive FDA 510(k) clearance?

PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT received FDA 510(k) clearance on 1992-08-26, under 510(k) number K923569.

Who is the listed applicant for PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT?

The FDA 510(k) record lists Baxter Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT?

The FDA product code for PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT is JMO.

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Other records listing Baxter Diagnostics, Inc. 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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Related Devices (Code: JMO)

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.

K113438ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K061464VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668Ortho-Clinical Diagnostics, Inc.K052867VITROS CHEMISTRY PRODUCTS DTIBC REAGENTOrtho-Clinical Diagnostics, Inc.K041793OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.K013102WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002Wiener Laboratories SaicK012340BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)Bayer 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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