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FDA 510(k)

PROGESTERONE TEST SET 125I 17-OH

K-Number: K834246 · 1984-02-04

ApplicantWien Laboratories, Inc.
Decision Date1984-02-04
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGESTERONE TEST SET 125I 17-OH is the device name listed in this FDA 510(k) record. The listed applicant is Wien Laboratories, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834246. 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 PROGESTERONE TEST SET 125I 17-OH?

PROGESTERONE TEST SET 125I 17-OH is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K834246.

When did PROGESTERONE TEST SET 125I 17-OH receive FDA 510(k) clearance?

PROGESTERONE TEST SET 125I 17-OH received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834246.

Who is the listed applicant for PROGESTERONE TEST SET 125I 17-OH?

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

What is the FDA product code for PROGESTERONE TEST SET 125I 17-OH?

The FDA product code for PROGESTERONE TEST SET 125I 17-OH is JLX.

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Other records listing Wien 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.

K912850SHBGK832452ANDROSTENEDIONE TEST SET 125IK823200125 I-DEHYDROEPIANDROSTERONE SULFATEK821653PROTRIPTYLINE TRI-CY TEST SETK821652DOXEPIN TRI-CY TEST SETK802728125I-TESTOSTERONE TEST SET

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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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