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)

KINYOUN ACID FAST STAIN KIT

K-Number: K851493 · 1985-04-29

ApplicantAccra Laboratories, Inc.
Decision Date1985-04-29
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KINYOUN ACID FAST STAIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Accra Laboratories, Inc.. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K851493. 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 KINYOUN ACID FAST STAIN KIT?

KINYOUN ACID FAST STAIN KIT is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K851493.

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

KINYOUN ACID FAST STAIN KIT received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851493.

Who is the listed applicant for KINYOUN ACID FAST STAIN KIT?

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

What is the FDA product code for KINYOUN ACID FAST STAIN KIT?

The FDA product code for KINYOUN ACID FAST STAIN KIT is JTS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Accra Laboratories, 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.

K851494TWO-STEP ACID FAST BACTERIA STAINK843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6K843426EOSIN Y 1% ALCOHOLICK843428BIOFIXK843429GRAM STAIN SET W/STABILIZED IODINE

View all 20 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.

K960095BACTIDROP CALCOFLUOR WHITERemel Co.K960090CALCOFLUOR WHITE STAIN KITRemel Co.K920970BACTIDROP KOH (10%)Remel Co.K920975BACTIDROP CALCOFLUOR WHITERemel Co.K920976BACTIDROP INDIA INKRemel Co.K893530IRISTAIN FORMULA 2, PARTS 1 AND 2Intl. Remote Imaging Systems

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.

↑