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FDA 510(k)

VENTREZYME EIA CONTROLS-IMMUNOASSAY

K-Number: K833423 · 1983-12-08

ApplicantVentrex Laboratories, Inc.
Decision Date1983-12-08
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTREZYME EIA CONTROLS-IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1983-12-08 under 510(k) number K833423. 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 VENTREZYME EIA CONTROLS-IMMUNOASSAY?

VENTREZYME EIA CONTROLS-IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K833423.

When did VENTREZYME EIA CONTROLS-IMMUNOASSAY receive FDA 510(k) clearance?

VENTREZYME EIA CONTROLS-IMMUNOASSAY received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833423.

Who is the listed applicant for VENTREZYME EIA CONTROLS-IMMUNOASSAY?

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

What is the FDA product code for VENTREZYME EIA CONTROLS-IMMUNOASSAY?

The FDA product code for VENTREZYME EIA CONTROLS-IMMUNOASSAY is JJY.

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Other records listing Ventrex Laboratories, 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.

K914554SPECIFIC IGE EIA-TURBO ASSAYK913833VENTREX ALLERGEN DISCK913434VENTREX COATED TUBE INTACT PTHK905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYK905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYK905247SHBG IRMA KIT

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Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit 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 LaboratoriesK153712VK-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 LaboratoriesK132156RANDOX 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.

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