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FDA 510(k)

FRESHCELLS

K-Number: K972414 · 1997-08-29

ApplicantDiagnostic Hybrids, Inc.
Decision Date1997-08-29
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FRESHCELLS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Hybrids, Inc.. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K972414. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESHCELLS?

FRESHCELLS is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K972414.

When did FRESHCELLS receive FDA 510(k) clearance?

FRESHCELLS received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972414.

Who is the listed applicant for FRESHCELLS?

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

What is the FDA product code for FRESHCELLS?

The FDA product code for FRESHCELLS is KIR.

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Other records listing Diagnostic Hybrids, Inc. as applicant

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Related Devices (Code: KIR)

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.

K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.K973209FRESH CELLS VERODiagnostic Hybrids, Inc.K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.K973214FRESH CELLS HFFDiagnostic Hybrids, Inc.

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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