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FDA 510(k)

NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D

K-Number: K101392 · 2011-02-04

ApplicantAstoria-Pacific, Inc.
Decision Date2011-02-04
Product CodeKQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D 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 2011-02-04 under 510(k) number K101392. 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 NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D?

NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D is a medical device that received FDA 510(k) clearance on 2011-02-04. The listed applicant is Astoria-Pacific, Inc.. The 510(k) number is K101392.

When did NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D receive FDA 510(k) clearance?

NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D received FDA 510(k) clearance on 2011-02-04, under 510(k) number K101392.

Who is the listed applicant for NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D?

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 NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D?

The FDA product code for NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D is KQP.

Related Clinical Trials

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 KITK102643SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KITK090940SPOTCHECK 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.

K102643SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KITAstoria-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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