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FDA 510(k)

DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL

K-Number: K922387 · 1992-07-15

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-07-15
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL 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 1992-07-15 under 510(k) number K922387. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL?

DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL is a medical device that received FDA 510(k) clearance on 1992-07-15. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K922387.

When did DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL receive FDA 510(k) clearance?

DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL received FDA 510(k) clearance on 1992-07-15, under 510(k) number K922387.

Who is the listed applicant for DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL?

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 DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL?

The FDA product code for DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL is DDR.

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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: DDR)

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.

K231832Access MyoglobinBeckman Coulter, Inc.K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme LaboratoriesK122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche DiagnosticsK080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche 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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