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FDA 510(k)

UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN

K-Number: K881438 · 1988-07-06

ApplicantHichem Diagnostics
Decision Date1988-07-06
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1988-07-06 under 510(k) number K881438. 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 UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN?

UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN is a medical device that received FDA 510(k) clearance on 1988-07-06. The listed applicant is Hichem Diagnostics. The 510(k) number is K881438.

When did UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN receive FDA 510(k) clearance?

UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN received FDA 510(k) clearance on 1988-07-06, under 510(k) number K881438.

Who is the listed applicant for UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN?

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

What is the FDA product code for UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN?

The FDA product code for UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN is JJY.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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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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