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FDA 510(k)

SANDARE ACID PHOSPHATASE PROCEDURE

K-Number: K842516 · 1984-08-17

ApplicantSandare Chemical Co., Inc.
Decision Date1984-08-17
Product CodeCJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SANDARE ACID PHOSPHATASE PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K842516. The device is classified under product code CJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDARE ACID PHOSPHATASE PROCEDURE?

SANDARE ACID PHOSPHATASE PROCEDURE is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K842516.

When did SANDARE ACID PHOSPHATASE PROCEDURE receive FDA 510(k) clearance?

SANDARE ACID PHOSPHATASE PROCEDURE received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842516.

Who is the listed applicant for SANDARE ACID PHOSPHATASE PROCEDURE?

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

What is the FDA product code for SANDARE ACID PHOSPHATASE PROCEDURE?

The FDA product code for SANDARE ACID PHOSPHATASE PROCEDURE is CJR.

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Other records listing Sandare Chemical Co., 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.

K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TESTK862556SANDARE GLYCOHEMOGLOBIN PROCEDUREK860684SANDARE BCG ALBUMIN PROCEDUREK851395SANDARE IRON-BINDING CAPACITY PROCEDUREK851394SANDARE IRON PROCEDUREK844498SANDARE ALKALINE PHOSPHATASE PROCEDURE

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Related Devices (Code: CJR)

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.

K760161TEST, ACID PHOSPHATASEPrinceton Biomedix

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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