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FDA 510(k)

ALK-PHOS BIOPAK GEL

K-Number: K810144 · 1981-02-02

ApplicantBioware Products
Decision Date1981-02-02
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALK-PHOS BIOPAK GEL is the device name listed in this FDA 510(k) record. The listed applicant is Bioware Products. It received FDA 510(k) clearance on 1981-02-02 under 510(k) number K810144. 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 ALK-PHOS BIOPAK GEL?

ALK-PHOS BIOPAK GEL is a medical device that received FDA 510(k) clearance on 1981-02-02. The listed applicant is Bioware Products. The 510(k) number is K810144.

When did ALK-PHOS BIOPAK GEL receive FDA 510(k) clearance?

ALK-PHOS BIOPAK GEL received FDA 510(k) clearance on 1981-02-02, under 510(k) number K810144.

Who is the listed applicant for ALK-PHOS BIOPAK GEL?

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

What is the FDA product code for ALK-PHOS BIOPAK GEL?

The FDA product code for ALK-PHOS BIOPAK GEL is CIN.

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 Bioware Products 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.

K802299K/K (ASMA/ANA) UNIVERSAL BIOPAKK802308T/K (ATA/AMA) UNIVERSAL BIOPAKK802276FTA-ABS BIOPAK

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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