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FDA 510(k)

ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14

K-Number: K912809 · 1991-08-12

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-08-12
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 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 1991-08-12 under 510(k) number K912809. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14?

ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K912809.

When did ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 receive FDA 510(k) clearance?

ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 received FDA 510(k) clearance on 1991-08-12, under 510(k) number K912809.

Who is the listed applicant for ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14?

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 ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14?

The FDA product code for ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 is CEO.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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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