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FDA 510(k)

17-HYDROXYPROGESTERONE TEST SET

K-Number: K771729 · 1977-10-21

ApplicantWien Laboratories, Inc.
Decision Date1977-10-21
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

17-HYDROXYPROGESTERONE TEST SET 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 1977-10-21 under 510(k) number K771729. 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 17-HYDROXYPROGESTERONE TEST SET?

17-HYDROXYPROGESTERONE TEST SET is a medical device that received FDA 510(k) clearance on 1977-10-21. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K771729.

When did 17-HYDROXYPROGESTERONE TEST SET receive FDA 510(k) clearance?

17-HYDROXYPROGESTERONE TEST SET received FDA 510(k) clearance on 1977-10-21, under 510(k) number K771729.

Who is the listed applicant for 17-HYDROXYPROGESTERONE TEST SET?

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 17-HYDROXYPROGESTERONE TEST SET?

The FDA product code for 17-HYDROXYPROGESTERONE TEST SET 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.

K912850SHBGK834246PROGESTERONE TEST SET 125I 17-OHK832452ANDROSTENEDIONE TEST SET 125IK823200125 I-DEHYDROEPIANDROSTERONE SULFATEK821653PROTRIPTYLINE TRI-CY TEST SETK821652DOXEPIN TRI-CY 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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