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)

WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001

K-Number: K012326 · 2001-11-08

ApplicantWiener Laboratories Saic
Decision Date2001-11-08
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 is the device name listed in this FDA 510(k) record. The listed applicant is Wiener Laboratories Saic. It received FDA 510(k) clearance on 2001-11-08 under 510(k) number K012326. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001?

WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 is a medical device that received FDA 510(k) clearance on 2001-11-08. The listed applicant is Wiener Laboratories Saic. The 510(k) number is K012326.

When did WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 receive FDA 510(k) clearance?

WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 received FDA 510(k) clearance on 2001-11-08, under 510(k) number K012326.

Who is the listed applicant for WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001?

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

What is the FDA product code for WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001?

The FDA product code for WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 is JGJ.

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 Wiener Laboratories Saic 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.

K023889WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254K024305WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006K024116WIENER LAB. BILIRUBINA DIRECT AAK023992WIENER LAB COLINESTERASA AAK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354K023551WIENER LAB GOT (AST) UV AA LIQUIDA

View all 24 devices →

Related Devices (Code: JGJ)

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.

K181748MagnesiumAbbott LaboratoriesK173294MagnesiumAbbott LaboratoriesK162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd.K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc.K122302ACE MAGNESIUM REGENTAlfa Wassermann Diagnostics Technologies, LLCK111915MAGNESIUM ASSAYSekisui Diagnostics P.E.I., 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.

↑