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FDA 510(k)

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT

K-Number: K102643 · 2011-07-15

ApplicantAstoria-Pacific, Inc.
Decision Date2011-07-15
Product CodeKQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Astoria-Pacific, Inc.. It received FDA 510(k) clearance on 2011-07-15 under 510(k) number K102643. 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 SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT?

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT is a medical device that received FDA 510(k) clearance on 2011-07-15. The listed applicant is Astoria-Pacific, Inc.. The 510(k) number is K102643.

When did SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT receive FDA 510(k) clearance?

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT received FDA 510(k) clearance on 2011-07-15, under 510(k) number K102643.

Who is the listed applicant for SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT?

The FDA 510(k) record lists Astoria-Pacific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT?

The FDA product code for SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT is KQP.

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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.

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Other records listing Astoria-Pacific, Inc. 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.

K121101SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KITK101392NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350DK090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDK080294ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KITK010844ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13KK990957ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K

View all 9 devices →

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.

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.K894011TOTAL GALACTOSEAlpkem Corp.

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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