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)

BIO SPEC GRAMAFLUOR TEST KIT

K-Number: K860091 · 1986-01-21

ApplicantBio Spec, Inc.
Decision Date1986-01-21
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIO SPEC GRAMAFLUOR TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio Spec, Inc.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K860091. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO SPEC GRAMAFLUOR TEST KIT?

BIO SPEC GRAMAFLUOR TEST KIT is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Bio Spec, Inc.. The 510(k) number is K860091.

When did BIO SPEC GRAMAFLUOR TEST KIT receive FDA 510(k) clearance?

BIO SPEC GRAMAFLUOR TEST KIT received FDA 510(k) clearance on 1986-01-21, under 510(k) number K860091.

Who is the listed applicant for BIO SPEC GRAMAFLUOR TEST KIT?

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

What is the FDA product code for BIO SPEC GRAMAFLUOR TEST KIT?

The FDA product code for BIO SPEC GRAMAFLUOR TEST KIT is JTO.

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 Bio Spec, 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.

K860041STREP D FLUORK841479BIO SPEC STREP-A-FLUOR TEST KIT

Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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.

↑