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FDA 510(k)

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT

K-Number: K934013 · 1994-04-26

ApplicantIsolab, Inc.
Decision Date1994-04-26
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K934013. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT?

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Isolab, Inc.. The 510(k) number is K934013.

When did RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT receive FDA 510(k) clearance?

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT received FDA 510(k) clearance on 1994-04-26, under 510(k) number K934013.

Who is the listed applicant for RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT?

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

What is the FDA product code for RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT?

The FDA product code for RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT is CIN.

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Other records listing Isolab, 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.

K951014ISOLAB'S T4 TEST KITK950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK943547PHENYLALANINE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS

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Related Devices (Code: CIN)

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.

K232904Access OstaseBeckman CoulterK200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OYK020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena LaboratoriesK011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)SebiaK994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, 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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