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FDA 510(k)

SYSTEMATE BUN HEM NO. 67221

K-Number: K843326 · 1984-09-14

ApplicantEm Diagnostic Systems, Inc.
Decision Date1984-09-14
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE BUN HEM NO. 67221 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1984-09-14 under 510(k) number K843326. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE BUN HEM NO. 67221?

SYSTEMATE BUN HEM NO. 67221 is a medical device that received FDA 510(k) clearance on 1984-09-14. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K843326.

When did SYSTEMATE BUN HEM NO. 67221 receive FDA 510(k) clearance?

SYSTEMATE BUN HEM NO. 67221 received FDA 510(k) clearance on 1984-09-14, under 510(k) number K843326.

Who is the listed applicant for SYSTEMATE BUN HEM NO. 67221?

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

What is the FDA product code for SYSTEMATE BUN HEM NO. 67221?

The FDA product code for SYSTEMATE BUN HEM NO. 67221 is CDQ.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CDQ)

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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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