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FDA 510(k)

RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2

K-Number: K031101 · 2003-06-16

ApplicantHemagen Diagnostics, Inc.
Decision Date2003-06-16
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 2003-06-16 under 510(k) number K031101. 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 RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2?

RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 is a medical device that received FDA 510(k) clearance on 2003-06-16. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K031101.

When did RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 receive FDA 510(k) clearance?

RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 received FDA 510(k) clearance on 2003-06-16, under 510(k) number K031101.

Who is the listed applicant for RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2?

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

What is the FDA product code for RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2?

The FDA product code for RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 is JJY.

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Other records listing Hemagen Diagnostics, Inc. as applicant

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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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