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FDA 510(k)

BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST

K-Number: K973350 · 1998-02-09

ApplicantBio-Rad
Decision Date1998-02-09
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1998-02-09 under 510(k) number K973350. 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 BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST?

BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST is a medical device that received FDA 510(k) clearance on 1998-02-09. The listed applicant is Bio-Rad. The 510(k) number is K973350.

When did BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST receive FDA 510(k) clearance?

BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST received FDA 510(k) clearance on 1998-02-09, under 510(k) number K973350.

Who is the listed applicant for BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST?

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

What is the FDA product code for BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST?

The FDA product code for BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST is JLX.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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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