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FDA 510(k)

DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III

K-Number: K926046 · 1993-01-05

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-01-05
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III 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 1993-01-05 under 510(k) number K926046. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III?

DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III is a medical device that received FDA 510(k) clearance on 1993-01-05. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K926046.

When did DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III receive FDA 510(k) clearance?

DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III received FDA 510(k) clearance on 1993-01-05, under 510(k) number K926046.

Who is the listed applicant for DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III?

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) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III?

The FDA product code for DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III is JJY.

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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.

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Related Devices (Code: JJY)

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.

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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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