FDA 510(k)

VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001

K-Number: K012117 · 2001-08-20

Decision Date2001-08-20

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 is the device name listed in this FDA 510(k) record. The listed applicant is Maine Standards Co.. It received FDA 510(k) clearance on 2001-08-20 under 510(k) number K012117. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001?

VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 is a medical device that received FDA 510(k) clearance on 2001-08-20. The listed applicant is Maine Standards Co.. The 510(k) number is K012117.

When did VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 receive FDA 510(k) clearance?

VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 received FDA 510(k) clearance on 2001-08-20, under 510(k) number K012117.

Who is the listed applicant for VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001?

The FDA 510(k) record lists Maine Standards Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001?

The FDA product code for VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 is JJY.

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 Maine Standards Co. as applicant

K123127VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 K113524VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT K103271MSC LIPID CONTROL K091225VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET K090475VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 K083891VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901

View all 23 devices →

Related Devices (Code: JJY)

K162530Multichem IA PlusTechno-Path Manufacturing K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad Laboratories K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad Laboratories K132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, 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.