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FDA 510(k)

ALBUMIN REAGENT

K-Number: K890333 · 1989-02-17

ApplicantAlpkem Corp.
Decision Date1989-02-17
Product CodeEIX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALBUMIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K890333. The device is classified under product code EIX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN REAGENT?

ALBUMIN REAGENT is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Alpkem Corp.. The 510(k) number is K890333.

When did ALBUMIN REAGENT receive FDA 510(k) clearance?

ALBUMIN REAGENT received FDA 510(k) clearance on 1989-02-17, under 510(k) number K890333.

Who is the listed applicant for ALBUMIN REAGENT?

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

What is the FDA product code for ALBUMIN REAGENT?

The FDA product code for ALBUMIN REAGENT is EIX.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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Related Devices (Code: EIX)

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.

K960245VIP VICTOR INTERACTIVE PROBEPro-DentecK944848THE VIVACARE T.P.S. PROBERms Div.K936221PROBE TIP/PERI PROBE/PERI PROBE COMP.Pd International ABK880827ACCUTEK PERIODONTAL PROBESweet Micro Systems, Inc.K875076FLORIDA PROBEFlorida Probe Corp.K870280ACCUDENT ACCUPROBEAccudent, Inc.

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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