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FDA 510(k)

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE

K-Number: K971508 · 1997-09-17

ApplicantBio-Whittaker, Inc., A Cambrex Co.
Decision Date1997-09-17
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Whittaker, Inc., A Cambrex Co.. It received FDA 510(k) clearance on 1997-09-17 under 510(k) number K971508. 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 RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE?

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE is a medical device that received FDA 510(k) clearance on 1997-09-17. The listed applicant is Bio-Whittaker, Inc., A Cambrex Co.. The 510(k) number is K971508.

When did RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE receive FDA 510(k) clearance?

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE received FDA 510(k) clearance on 1997-09-17, under 510(k) number K971508.

Who is the listed applicant for RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE?

The FDA 510(k) record lists Bio-Whittaker, Inc., A Cambrex Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE?

The FDA product code for RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE is KIR.

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Other records listing Bio-Whittaker, Inc., A Cambrex Co. 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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