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FDA 510(k)

DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)

K-Number: K943148 · 1994-11-10

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1994-11-10
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) 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 1994-11-10 under 510(k) number K943148. The device is classified under product code JLX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)?

DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K943148.

When did DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) receive FDA 510(k) clearance?

DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) received FDA 510(k) clearance on 1994-11-10, under 510(k) number K943148.

Who is the listed applicant for DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)?

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 ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)?

The FDA product code for DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) is JLX.

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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: JLX)

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.

K100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UWallac OYK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OYK062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEDrg Intl., Inc.K060452ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAHNeo-GenesisK050960MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KITWallac OYK042424DELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OY

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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