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FDA 510(k)

DADE STRATUS TROPONIN-I CONTROL

K-Number: K951888 · 1995-07-13

ApplicantDade Intl., Inc.
Decision Date1995-07-13
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE STRATUS TROPONIN-I CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1995-07-13 under 510(k) number K951888. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE STRATUS TROPONIN-I CONTROL?

DADE STRATUS TROPONIN-I CONTROL is a medical device that received FDA 510(k) clearance on 1995-07-13. The listed applicant is Dade Intl., Inc.. The 510(k) number is K951888.

When did DADE STRATUS TROPONIN-I CONTROL receive FDA 510(k) clearance?

DADE STRATUS TROPONIN-I CONTROL received FDA 510(k) clearance on 1995-07-13, under 510(k) number K951888.

Who is the listed applicant for DADE STRATUS TROPONIN-I CONTROL?

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

What is the FDA product code for DADE STRATUS TROPONIN-I CONTROL?

The FDA product code for DADE STRATUS TROPONIN-I CONTROL is JJX.

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Other records listing Dade Intl., 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.

K974343DADE INNOVINK970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROLK973668CARDIAC TROPONIN-I (TROP) CALIBRATORK972524DRIED GRAM-POSITIVE MIC/COMBO PANELSK972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

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Related Devices (Code: JJX)

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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