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FDA 510(k)

CELL CULTURE LINES

K-Number: K780869 · 1978-08-14

ApplicantBioassay Systems Research Corp.
Decision Date1978-08-14
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL CULTURE LINES is the device name listed in this FDA 510(k) record. The listed applicant is Bioassay Systems Research Corp.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K780869. 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 CELL CULTURE LINES?

CELL CULTURE LINES is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Bioassay Systems Research Corp.. The 510(k) number is K780869.

When did CELL CULTURE LINES receive FDA 510(k) clearance?

CELL CULTURE LINES received FDA 510(k) clearance on 1978-08-14, under 510(k) number K780869.

Who is the listed applicant for CELL CULTURE LINES?

The FDA 510(k) record lists Bioassay Systems Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELL CULTURE LINES?

The FDA product code for CELL CULTURE LINES is KIR.

Related Clinical Trials

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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Other records listing Bioassay Systems Research Corp. 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.

K850990HFF GENCELLSK771867MYCOPLASMA DETECTION KIT

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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