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FDA 510(k)

TOTAL GALACTOSE

K-Number: K894011 · 1990-01-11

ApplicantAlpkem Corp.
Decision Date1990-01-11
Product CodeKQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL GALACTOSE is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K894011. The device is classified under product code KQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL GALACTOSE?

TOTAL GALACTOSE is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is Alpkem Corp.. The 510(k) number is K894011.

When did TOTAL GALACTOSE receive FDA 510(k) clearance?

TOTAL GALACTOSE received FDA 510(k) clearance on 1990-01-11, under 510(k) number K894011.

Who is the listed applicant for TOTAL GALACTOSE?

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 TOTAL GALACTOSE?

The FDA product code for TOTAL GALACTOSE is KQP.

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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.

K891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTERK890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.

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Related Devices (Code: KQP)

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.

K102643SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KITAstoria-Pacific, Inc.K101392NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350DAstoria-Pacific, Inc.K100101GSP NEONATALGALT KIT, MODEL 3303-001UPerkinelmer, Inc.K993536BIO-RAD CODA NEONATAL GALT ASSAYBio-RadK990827MICROPLATE NEONATAL GALT ASSAYBio-RadK970277URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)Astoria-Pacific, 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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