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FDA 510(k)

UNASSAYED CONTROL SERUM, NORMAL (BOVINE)

K-Number: K872304 · 1987-07-07

ApplicantVanguard Diagnostic Systems
Decision Date1987-07-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNASSAYED CONTROL SERUM, NORMAL (BOVINE) is the device name listed in this FDA 510(k) record. The listed applicant is Vanguard Diagnostic Systems. It received FDA 510(k) clearance on 1987-07-07 under 510(k) number K872304. 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 UNASSAYED CONTROL SERUM, NORMAL (BOVINE)?

UNASSAYED CONTROL SERUM, NORMAL (BOVINE) is a medical device that received FDA 510(k) clearance on 1987-07-07. The listed applicant is Vanguard Diagnostic Systems. The 510(k) number is K872304.

When did UNASSAYED CONTROL SERUM, NORMAL (BOVINE) receive FDA 510(k) clearance?

UNASSAYED CONTROL SERUM, NORMAL (BOVINE) received FDA 510(k) clearance on 1987-07-07, under 510(k) number K872304.

Who is the listed applicant for UNASSAYED CONTROL SERUM, NORMAL (BOVINE)?

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

What is the FDA product code for UNASSAYED CONTROL SERUM, NORMAL (BOVINE)?

The FDA product code for UNASSAYED CONTROL SERUM, NORMAL (BOVINE) 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.

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Other records listing Vanguard Diagnostic Systems 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.

K872303UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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