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)

AMIZYME-LEISHMANIA SPP. TEST KIT

K-Number: K842526 · 1984-08-28

ApplicantAmico Lab, Inc.
Decision Date1984-08-28
Product CodeLOO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMIZYME-LEISHMANIA SPP. TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amico Lab, Inc.. It received FDA 510(k) clearance on 1984-08-28 under 510(k) number K842526. The device is classified under product code LOO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIZYME-LEISHMANIA SPP. TEST KIT?

AMIZYME-LEISHMANIA SPP. TEST KIT is a medical device that received FDA 510(k) clearance on 1984-08-28. The listed applicant is Amico Lab, Inc.. The 510(k) number is K842526.

When did AMIZYME-LEISHMANIA SPP. TEST KIT receive FDA 510(k) clearance?

AMIZYME-LEISHMANIA SPP. TEST KIT received FDA 510(k) clearance on 1984-08-28, under 510(k) number K842526.

Who is the listed applicant for AMIZYME-LEISHMANIA SPP. TEST KIT?

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

What is the FDA product code for AMIZYME-LEISHMANIA SPP. TEST KIT?

The FDA product code for AMIZYME-LEISHMANIA SPP. TEST KIT is LOO.

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 Amico Lab, 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.

K842662ANTI-EPSTEIN-BARR VIRUS KITK842530AMIZYME-EBV TEST KITK842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2K842531AMIZYME-HSV TYPES 1 & 2 TEST KITSK842529AMIZYME-CMV KITK842661ANTI-CYTOMEGALOVIRUS KIT

View all 32 devices →

Related Devices (Code: LOO)

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.

K023483KALAZAR DETECTInbios Intl., 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.

↑