FDA 510(k)

N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H

K-Number: K052788 · 2006-03-29

Decision Date2006-03-29

Product CodeLPS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-03-29 under 510(k) number K052788. The device is classified under product code LPS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H?

N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is Dade Behring, Inc.. The 510(k) number is K052788.

When did N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H receive FDA 510(k) clearance?

N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H received FDA 510(k) clearance on 2006-03-29, under 510(k) number K052788.

Who is the listed applicant for N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H?

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

What is the FDA product code for N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H?

The FDA product code for N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H is LPS.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dade Behring, Inc. as applicant

K093848PT-MULTI-CALIBRATOR, MODEL OPAT07 K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST K081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

View all 343 devices →

Related Devices (Code: LPS)

K123930VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K121053DIAZYME HOMOCYSTEINE POC TEST KITDiazyme Laboratories K121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc.K113793HOMOCYSTEINE TESTRoche K112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONAxis-Shield Diagnostics, Ltd.K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Axis-Shield Diagnostics, Ltd.

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.