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)

FITC ANTISERA TO HUMAN IGG

K-Number: K822676 · 1982-11-17

ApplicantAmico Lab, Inc.
Decision Date1982-11-17
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FITC ANTISERA TO HUMAN IGG 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 1982-11-17 under 510(k) number K822676. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITC ANTISERA TO HUMAN IGG?

FITC ANTISERA TO HUMAN IGG is a medical device that received FDA 510(k) clearance on 1982-11-17. The listed applicant is Amico Lab, Inc.. The 510(k) number is K822676.

When did FITC ANTISERA TO HUMAN IGG receive FDA 510(k) clearance?

FITC ANTISERA TO HUMAN IGG received FDA 510(k) clearance on 1982-11-17, under 510(k) number K822676.

Who is the listed applicant for FITC ANTISERA TO HUMAN IGG?

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 FITC ANTISERA TO HUMAN IGG?

The FDA product code for FITC ANTISERA TO HUMAN IGG is DFH.

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: DFH)

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.

K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2SebiaK211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, 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.

↑