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FDA 510(k)

SANTEST 1AP

K-Number: K862087 · 1986-12-03

ApplicantScientific Sales Intl., Inc.
Decision Date1986-12-03
Product CodeLKL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SANTEST 1AP is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Sales Intl., Inc.. It received FDA 510(k) clearance on 1986-12-03 under 510(k) number K862087. The device is classified under product code LKL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANTEST 1AP?

SANTEST 1AP is a medical device that received FDA 510(k) clearance on 1986-12-03. The listed applicant is Scientific Sales Intl., Inc.. The 510(k) number is K862087.

When did SANTEST 1AP receive FDA 510(k) clearance?

SANTEST 1AP received FDA 510(k) clearance on 1986-12-03, under 510(k) number K862087.

Who is the listed applicant for SANTEST 1AP?

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

What is the FDA product code for SANTEST 1AP?

The FDA product code for SANTEST 1AP is LKL.

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 Scientific Sales Intl., 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.

K953677LIGHTED FLEXGUIDE (MODIFICATION)K940799FLEXGUIDEK860996SANASSAY IC TESTK861336IAP PLATE TESTK853285MYWASHER 5K853284MYREADER 7

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Related Devices (Code: LKL)

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.

K993441K-ASSAY ALPHA-1 AGKamiya Biomedical Co.K964299N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.K964257IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENTBeckman Instruments, Inc.K922417AL-ACID GLYCOPROTEIN RID KITThe Binding Site, Ltd.K904175RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENTReagents Applications, Inc.K884217TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEINTechnicon Instruments Corp.

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.

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