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FDA 510(k)

CELL

K-Number: K780305 · 1978-03-27

ApplicantDynatech Laboratories, Inc.
Decision Date1978-03-27
Product CodeKJF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Laboratories, Inc.. It received FDA 510(k) clearance on 1978-03-27 under 510(k) number K780305. The device is classified under product code KJF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL?

CELL is a medical device that received FDA 510(k) clearance on 1978-03-27. The listed applicant is Dynatech Laboratories, Inc.. The 510(k) number is K780305.

When did CELL receive FDA 510(k) clearance?

CELL received FDA 510(k) clearance on 1978-03-27, under 510(k) number K780305.

Who is the listed applicant for CELL?

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

What is the FDA product code for CELL?

The FDA product code for CELL is KJF.

Related PubMed Literature

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.

PMID: 42722334Regulating cell and xeno-transplants: Learning from medical device oversight.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons ()PMID: 39334246Post-marketing surveillance framework of cell and gene therapy products in the European Union, the United States, Japan, South Korea and China: a comparative study.BMC medicine ()

Other records listing Dynatech Laboratories, Inc. as applicant

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Related Devices (Code: KJF)

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.

K893787LIFECELL RECOVERY CONTAINERBaxter Healthcare CorpK892645AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SYAmicon, Inc.K875221TOOTH PRESERVING SYSTEMBiological Rescue Products, 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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