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FDA 510(k)

CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2

K-Number: K924599 · 1992-10-15

ApplicantEm Diagnostic Systems, Inc.
Decision Date1992-10-15
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 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 1992-10-15 under 510(k) number K924599. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2?

CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 is a medical device that received FDA 510(k) clearance on 1992-10-15. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K924599.

When did CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 receive FDA 510(k) clearance?

CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 received FDA 510(k) clearance on 1992-10-15, under 510(k) number K924599.

Who is the listed applicant for CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2?

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 CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2?

The FDA product code for CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 is CGX.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CGX)

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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