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FDA 510(k)

DSL 17A-OH PROGERSTERONE (DSL #6800)

K-Number: K894265 · 1989-09-07

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1989-09-07
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL 17A-OH PROGERSTERONE (DSL #6800) 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 1989-09-07 under 510(k) number K894265. 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 17A-OH PROGERSTERONE (DSL #6800)?

DSL 17A-OH PROGERSTERONE (DSL #6800) is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K894265.

When did DSL 17A-OH PROGERSTERONE (DSL #6800) receive FDA 510(k) clearance?

DSL 17A-OH PROGERSTERONE (DSL #6800) received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894265.

Who is the listed applicant for DSL 17A-OH PROGERSTERONE (DSL #6800)?

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 17A-OH PROGERSTERONE (DSL #6800)?

The FDA product code for DSL 17A-OH PROGERSTERONE (DSL #6800) is JLX.

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 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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