Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NDNA IMMUNOPATH FLUORO-KIT

K-Number: K770057 · 1977-04-05

Decision Date1977-04-05
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NDNA IMMUNOPATH FLUORO-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770057. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NDNA IMMUNOPATH FLUORO-KIT?

NDNA IMMUNOPATH FLUORO-KIT is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K770057.

When did NDNA IMMUNOPATH FLUORO-KIT receive FDA 510(k) clearance?

NDNA IMMUNOPATH FLUORO-KIT received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770057.

Who is the listed applicant for NDNA IMMUNOPATH FLUORO-KIT?

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

What is the FDA product code for NDNA IMMUNOPATH FLUORO-KIT?

The FDA product code for NDNA IMMUNOPATH FLUORO-KIT is DHN.

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.

Other records listing Clinical Sciences, Inc. 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.

View all 30 devices →

Related Devices (Code: DHN)

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.

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.

↑