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FDA 510(k)

TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY

K-Number: K936171 · 1994-02-03

ApplicantAdvanced Clinical Diagnostics
Decision Date1994-02-03
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Clinical Diagnostics. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K936171. 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 TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY?

TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Advanced Clinical Diagnostics. The 510(k) number is K936171.

When did TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY receive FDA 510(k) clearance?

TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY received FDA 510(k) clearance on 1994-02-03, under 510(k) number K936171.

Who is the listed applicant for TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY?

The FDA 510(k) record lists Advanced Clinical Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY?

The FDA product code for TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY is KIR.

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Other records listing Advanced Clinical Diagnostics 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.

K936169RHESUS MONKEY KIDNEY CELLSK936172RHESUS MONKEY KIDNEY CELLS (LLC-MK2)K934934RABBIT KIDNEY CELLS - R.K.C.K934973HELA-229/HELA CELLSK935766PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLSK934241MCCOY CULTURE CELLS-MCCOY

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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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