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FDA 510(k)

DELFIA CORTISOL KIT

K-Number: K930732 · 1993-07-27

ApplicantWallac OY
Decision Date1993-07-27
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA CORTISOL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K930732. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELFIA CORTISOL KIT?

DELFIA CORTISOL KIT is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Wallac OY. The 510(k) number is K930732.

When did DELFIA CORTISOL KIT receive FDA 510(k) clearance?

DELFIA CORTISOL KIT received FDA 510(k) clearance on 1993-07-27, under 510(k) number K930732.

Who is the listed applicant for DELFIA CORTISOL KIT?

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

What is the FDA product code for DELFIA CORTISOL KIT?

The FDA product code for DELFIA CORTISOL KIT is JFT.

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Other records listing Wallac OY 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.

K131284GSP NEONATAL BIOTINIDASE KITK100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITK071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BK070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

View all 21 devices →

Related Devices (Code: JFT)

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.

K242505Elecsys Cortisol IIIRoche DiagnosticsK192788ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc.K152227Elecsys Cortisol II, Cortisol II CalSetRoche DiagnosticsK062204ARCHITECT CORTISOL ASSAYSeradyn, Inc.K033731AXSYM CORTISOL ASSAYFujirebio Diagnostics,Inc.K021218ELECSYS CORTISOL TEST SYSTEMRoche Diagnostics Corp.

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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