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FDA 510(k)

MULTICONSTITUENT SERUM RANGE LINEARITY #88234

K-Number: K901115 · 1990-04-19

ApplicantHichem Diagnostics
Decision Date1990-04-19
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTICONSTITUENT SERUM RANGE LINEARITY #88234 is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1990-04-19 under 510(k) number K901115. 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 MULTICONSTITUENT SERUM RANGE LINEARITY #88234?

MULTICONSTITUENT SERUM RANGE LINEARITY #88234 is a medical device that received FDA 510(k) clearance on 1990-04-19. The listed applicant is Hichem Diagnostics. The 510(k) number is K901115.

When did MULTICONSTITUENT SERUM RANGE LINEARITY #88234 receive FDA 510(k) clearance?

MULTICONSTITUENT SERUM RANGE LINEARITY #88234 received FDA 510(k) clearance on 1990-04-19, under 510(k) number K901115.

Who is the listed applicant for MULTICONSTITUENT SERUM RANGE LINEARITY #88234?

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 MULTICONSTITUENT SERUM RANGE LINEARITY #88234?

The FDA product code for MULTICONSTITUENT SERUM RANGE LINEARITY #88234 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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