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FDA 510(k)

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR

K-Number: K871977 · 1987-07-09

ApplicantAmerican Dade
Decision Date1987-07-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1987-07-09 under 510(k) number K871977. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR?

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR is a medical device that received FDA 510(k) clearance on 1987-07-09. The listed applicant is American Dade. The 510(k) number is K871977.

When did DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR receive FDA 510(k) clearance?

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR received FDA 510(k) clearance on 1987-07-09, under 510(k) number K871977.

Who is the listed applicant for DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR?

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

What is the FDA product code for DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR?

The FDA product code for DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR is JJY.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: JJY)

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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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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