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)

TEST FOR HUMAN ALPHA ONE ACID GLYCO-

K-Number: K831960 · 1983-07-19

ApplicantKent Laboratories, Inc.
Decision Date1983-07-19
Product CodeLKL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TEST FOR HUMAN ALPHA ONE ACID GLYCO- is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831960. 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 TEST FOR HUMAN ALPHA ONE ACID GLYCO-?

TEST FOR HUMAN ALPHA ONE ACID GLYCO- is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K831960.

When did TEST FOR HUMAN ALPHA ONE ACID GLYCO- receive FDA 510(k) clearance?

TEST FOR HUMAN ALPHA ONE ACID GLYCO- received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831960.

Who is the listed applicant for TEST FOR HUMAN ALPHA ONE ACID GLYCO-?

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

What is the FDA product code for TEST FOR HUMAN ALPHA ONE ACID GLYCO-?

The FDA product code for TEST FOR HUMAN ALPHA ONE ACID GLYCO- 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 Kent 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.

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

View all 40 devices →

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.

↑