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FDA 510(k)

NO-HOIL COMBOSTAT II KIT

K-Number: K813310 · 1981-12-17

ApplicantRia Products, Inc.
Decision Date1981-12-17
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NO-HOIL COMBOSTAT II KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ria Products, Inc.. It received FDA 510(k) clearance on 1981-12-17 under 510(k) number K813310. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NO-HOIL COMBOSTAT II KIT?

NO-HOIL COMBOSTAT II KIT is a medical device that received FDA 510(k) clearance on 1981-12-17. The listed applicant is Ria Products, Inc.. The 510(k) number is K813310.

When did NO-HOIL COMBOSTAT II KIT receive FDA 510(k) clearance?

NO-HOIL COMBOSTAT II KIT received FDA 510(k) clearance on 1981-12-17, under 510(k) number K813310.

Who is the listed applicant for NO-HOIL COMBOSTAT II KIT?

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

What is the FDA product code for NO-HOIL COMBOSTAT II KIT?

The FDA product code for NO-HOIL COMBOSTAT II KIT is CDD.

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Other records listing Ria Products, 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.

K802969CORTISOL 125-I RADIOIMMUNOASSAY KITK801578COMBOSTAT - NO-BOIL KITK801579VITAMIN B12 - NO-BOIL KITK800710FERRITIRON KIT CAT. #RP-1100K800914NO-BOIL FOLATE KIT #RP-500K781844FERRITIN KIT

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Related Devices (Code: CDD)

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.

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories

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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