FDA 510(k)

DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET

K-Number: K950469 · 1995-04-11

Decision Date1995-04-11

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1995-04-11 under 510(k) number K950469. 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 DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET?

DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET is a medical device that received FDA 510(k) clearance on 1995-04-11. The listed applicant is Casco Standards. The 510(k) number is K950469.

When did DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET receive FDA 510(k) clearance?

DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET received FDA 510(k) clearance on 1995-04-11, under 510(k) number K950469.

Who is the listed applicant for DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET?

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

What is the FDA product code for DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET?

The FDA product code for DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET 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 Casco Standards as applicant

K981436DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 K972904DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL K962629DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR K962630DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL K961750DOCUMENT CARDIAC ASSAYED CONTROL K960244DOCUMENT TDM ULTRA ASSAYED CONTROL

View all 38 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.