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FDA 510(k)

CHEMPRO 1000(TM)

K-Number: K870860 · 1987-04-14

ApplicantArden Medical Systems, Inc.
Decision Date1987-04-14
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHEMPRO 1000(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Arden Medical Systems, Inc.. It received FDA 510(k) clearance on 1987-04-14 under 510(k) number K870860. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMPRO 1000(TM)?

CHEMPRO 1000(TM) is a medical device that received FDA 510(k) clearance on 1987-04-14. The listed applicant is Arden Medical Systems, Inc.. The 510(k) number is K870860.

When did CHEMPRO 1000(TM) receive FDA 510(k) clearance?

CHEMPRO 1000(TM) received FDA 510(k) clearance on 1987-04-14, under 510(k) number K870860.

Who is the listed applicant for CHEMPRO 1000(TM)?

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

What is the FDA product code for CHEMPRO 1000(TM)?

The FDA product code for CHEMPRO 1000(TM) is GKF.

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 Arden Medical Systems, 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.

K883012A.QC CHEMISTRY CONTROL LEVEL 2K873611A-QC CLINICAL CHEMISTRY CONTROL

Related Devices (Code: GKF)

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.

K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)Instrumentation Laboratory COK983551CRIT-SCAN II MONITORIn-Line Diagnostics Corp.K981427STAT PROFILE M ANALYZERNova Biomedical Corp.K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.K981426STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSNova Biomedical Corp.K953519MICROSPIN 24Vulcon Technologies

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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