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FDA 510(k)

IMMULITE DHEA-S04

K-Number: K935806 · 1994-04-26

ApplicantDiagnostic Products Corp.
Decision Date1994-04-26
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE DHEA-S04 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K935806. The device is classified under product code JKC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE DHEA-S04?

IMMULITE DHEA-S04 is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K935806.

When did IMMULITE DHEA-S04 receive FDA 510(k) clearance?

IMMULITE DHEA-S04 received FDA 510(k) clearance on 1994-04-26, under 510(k) number K935806.

Who is the listed applicant for IMMULITE DHEA-S04?

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

What is the FDA product code for IMMULITE DHEA-S04?

The FDA product code for IMMULITE DHEA-S04 is JKC.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 devices →

Related Devices (Code: JKC)

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.

K040181ACCESS DHEA-S REAGENT ASSAYBeckman Coulter, Inc.K003174ELECSYS DHEA-SRoche Diagnostics Corp.K973897DHEA-SKmi Diagnostics, Inc.K962895DSL DHEA-S-7Diagnostic Systems Laboratories, Inc.K955114DSL AACTIVE DHEA EIA KITDiagnostic Systems Laboratories, Inc.K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYNichols Institute

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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