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FDA 510(k)

IMR-90-DIPLOID-HUMAN FETAL LUNG CELL

K-Number: K841998 · 1984-06-27

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-06-27
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMR-90-DIPLOID-HUMAN FETAL LUNG CELL is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1984-06-27 under 510(k) number K841998. 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 IMR-90-DIPLOID-HUMAN FETAL LUNG CELL?

IMR-90-DIPLOID-HUMAN FETAL LUNG CELL is a medical device that received FDA 510(k) clearance on 1984-06-27. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K841998.

When did IMR-90-DIPLOID-HUMAN FETAL LUNG CELL receive FDA 510(k) clearance?

IMR-90-DIPLOID-HUMAN FETAL LUNG CELL received FDA 510(k) clearance on 1984-06-27, under 510(k) number K841998.

Who is the listed applicant for IMR-90-DIPLOID-HUMAN FETAL LUNG CELL?

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

What is the FDA product code for IMR-90-DIPLOID-HUMAN FETAL LUNG CELL?

The FDA product code for IMR-90-DIPLOID-HUMAN FETAL LUNG CELL is KIR.

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Other records listing Bartels Immunodiagnostic Supplies, 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.

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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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