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)

API UNISCEPT MIC 100UL

K-Number: K844159 · 1984-12-14

ApplicantAnalytical Products, Inc.
Decision Date1984-12-14
Product CodeLTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API UNISCEPT MIC 100UL is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1984-12-14 under 510(k) number K844159. The device is classified under product code LTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the API UNISCEPT MIC 100UL?

API UNISCEPT MIC 100UL is a medical device that received FDA 510(k) clearance on 1984-12-14. The listed applicant is Analytical Products, Inc.. The 510(k) number is K844159.

When did API UNISCEPT MIC 100UL receive FDA 510(k) clearance?

API UNISCEPT MIC 100UL received FDA 510(k) clearance on 1984-12-14, under 510(k) number K844159.

Who is the listed applicant for API UNISCEPT MIC 100UL?

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

What is the FDA product code for API UNISCEPT MIC 100UL?

The FDA product code for API UNISCEPT MIC 100UL is LTW.

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 Analytical Products, 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.

K924814API 20E/UNISCEPT 20EK923684API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MICK922926API UNISCEPT KB/TYPE 2 AND 3K901559MODIFICATION TO API UNISCEPT 20GPK901390DMAC INDOLE REAGENTK895796API UNISCEPT KB

View all 57 devices →

Related Devices (Code: LTW)

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.

K852613MIC-CONCEPT SYSTEMMicrotech Medical Systems, Inc.K853596PRECEPT CEFOPERAZONEAustin Biological LaboratoriesK853772PRECEPT METHICILLINAustin Biological LaboratoriesK853273PRECEPT CEFTRIAXONEAustin Biological LaboratoriesK853685PRECEPT TM CARBENICILLINAustin Biological LaboratoriesK853684PRECEPT KANAMYCINAustin Biological Laboratories

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.

↑