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FDA 510(k)

DSL CK-MB (DSL #3200)

K-Number: K904721 · 1990-12-13

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1990-12-13
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL CK-MB (DSL #3200) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K904721. The device is classified under product code JHT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL CK-MB (DSL #3200)?

DSL CK-MB (DSL #3200) is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K904721.

When did DSL CK-MB (DSL #3200) receive FDA 510(k) clearance?

DSL CK-MB (DSL #3200) received FDA 510(k) clearance on 1990-12-13, under 510(k) number K904721.

Who is the listed applicant for DSL CK-MB (DSL #3200)?

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

What is the FDA product code for DSL CK-MB (DSL #3200)?

The FDA product code for DSL CK-MB (DSL #3200) is JHT.

Other records listing Diagnostic Systems Laboratories, 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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Related Devices (Code: JHT)

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.

K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena LaboratoriesK904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, Inc.K896170REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083Helena Laboratories

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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