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)

ACID FAST KIT

K-Number: K781643 · 1978-10-03

ApplicantBioscientific
Decision Date1978-10-03
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACID FAST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioscientific. It received FDA 510(k) clearance on 1978-10-03 under 510(k) number K781643. The device is classified under product code JTS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACID FAST KIT?

ACID FAST KIT is a medical device that received FDA 510(k) clearance on 1978-10-03. The listed applicant is Bioscientific. The 510(k) number is K781643.

When did ACID FAST KIT receive FDA 510(k) clearance?

ACID FAST KIT received FDA 510(k) clearance on 1978-10-03, under 510(k) number K781643.

Who is the listed applicant for ACID FAST KIT?

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

What is the FDA product code for ACID FAST KIT?

The FDA product code for ACID FAST KIT is JTS.

Other records listing Bioscientific 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 16 devices →

Related Devices (Code: JTS)

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.

↑