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FDA 510(k)

FASTPACK CONTROL KIT

K-Number: K123725 · 2013-03-08

ApplicantQualigen, Inc.
Decision Date2013-03-08
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTPACK CONTROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Qualigen, Inc.. It received FDA 510(k) clearance on 2013-03-08 under 510(k) number K123725. 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 FASTPACK CONTROL KIT?

FASTPACK CONTROL KIT is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Qualigen, Inc.. The 510(k) number is K123725.

When did FASTPACK CONTROL KIT receive FDA 510(k) clearance?

FASTPACK CONTROL KIT received FDA 510(k) clearance on 2013-03-08, under 510(k) number K123725.

Who is the listed applicant for FASTPACK CONTROL KIT?

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

What is the FDA product code for FASTPACK CONTROL KIT?

The FDA product code for FASTPACK CONTROL KIT is JJY.

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Other records listing Qualigen, 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.

K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayK123983FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERSK101388FASTPACK TESTO IMMUNOASSAYK101390FASTPACK TSH IMMUNOASSAYK072264FASTPACK HCG IMMUNOASSAYK062957FASTPACK TOTAL PSA METHOD VERIFICATION 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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