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FDA 510(k)

FRESHCELLS, HEP-2

K-Number: K962780 · 1996-08-29

ApplicantDiagnostic Hybrids, Inc.
Decision Date1996-08-29
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FRESHCELLS, HEP-2 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 1996-08-29 under 510(k) number K962780. 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, HEP-2?

FRESHCELLS, HEP-2 is a medical device that received FDA 510(k) clearance on 1996-08-29. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K962780.

When did FRESHCELLS, HEP-2 receive FDA 510(k) clearance?

FRESHCELLS, HEP-2 received FDA 510(k) clearance on 1996-08-29, under 510(k) number K962780.

Who is the listed applicant for FRESHCELLS, HEP-2?

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, HEP-2?

The FDA product code for FRESHCELLS, HEP-2 is KIR.

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Other records listing Diagnostic Hybrids, 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: 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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