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FDA 510(k)

RFA/2 RAPID FLOW ANALYZER W/COMPUTER

K-Number: K890332 · 1989-02-17

ApplicantAlpkem Corp.
Decision Date1989-02-17
Product CodeJJC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RFA/2 RAPID FLOW ANALYZER W/COMPUTER 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 K890332. The device is classified under product code JJC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RFA/2 RAPID FLOW ANALYZER W/COMPUTER?

RFA/2 RAPID FLOW ANALYZER W/COMPUTER 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 K890332.

When did RFA/2 RAPID FLOW ANALYZER W/COMPUTER receive FDA 510(k) clearance?

RFA/2 RAPID FLOW ANALYZER W/COMPUTER received FDA 510(k) clearance on 1989-02-17, under 510(k) number K890332.

Who is the listed applicant for RFA/2 RAPID FLOW ANALYZER W/COMPUTER?

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 RFA/2 RAPID FLOW ANALYZER W/COMPUTER?

The FDA product code for RFA/2 RAPID FLOW ANALYZER W/COMPUTER is JJC.

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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) REAGENTK890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.

View all 33 devices →

Related Devices (Code: JJC)

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.

K945915AVL OMNI ANALYZERAvl Scientific Corp.K945584NOVA 16 ANALYZERNova Biomedical Corp.K943376OPERA SYSTEMMiles, Inc.K901410TECHNICON RA-2000(TM) SYSTEMTechnicon Instruments Corp.K901141PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZXBaxter Healthcare CorpK881056AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030American Research Products Co.

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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