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FDA 510(k)

ALKALINE PHOSPHATASE REAGENT SET

K-Number: K855192 · 1986-01-14

ApplicantTechnostics Intl.
Decision Date1986-01-14
Product CodeCIO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Technostics Intl.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K855192. The device is classified under product code CIO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATASE REAGENT SET?

ALKALINE PHOSPHATASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Technostics Intl.. The 510(k) number is K855192.

When did ALKALINE PHOSPHATASE REAGENT SET receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE REAGENT SET received FDA 510(k) clearance on 1986-01-14, under 510(k) number K855192.

Who is the listed applicant for ALKALINE PHOSPHATASE REAGENT SET?

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

What is the FDA product code for ALKALINE PHOSPHATASE REAGENT SET?

The FDA product code for ALKALINE PHOSPHATASE REAGENT SET is CIO.

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Other records listing Technostics Intl. 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.

K855188CPK (UV) REAGENT KITK860111URIC ACID REAGENT SETK855190MAGNESIUM REAGENT SETK860110GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SETK860109ENZYMATIC UREA NITROGEN REAGENT SETK860112TOTAL LIPIDS REAGENT SET

View all 21 devices →

Related Devices (Code: CIO)

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.

K880177ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHATTech-Co, Inc.K860351ALKALINE PHOSPHATASE REAGENT SETSterling Diagnostics, Inc.K844498SANDARE ALKALINE PHOSPHATASE PROCEDURESandare Chemical Co., Inc.K844237ALKALINE PHOSPHATASE REAGENT SETLivonia Diagnostics, Inc.K841064ALKALINE PHOSPHOTASE REAGENT SETMedical Specialties, Inc.K823578COBAS STANDARDS FOR CALCIUM-IN-ORGANICHoffmann-La Roche, 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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