Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACCUSCREEN 17-HYDROXYPROGESTERONE

K-Number: K934178 · 1995-03-30

ApplicantNeometrics, Inc.
Decision Date1995-03-30
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUSCREEN 17-HYDROXYPROGESTERONE is the device name listed in this FDA 510(k) record. The listed applicant is Neometrics, Inc.. It received FDA 510(k) clearance on 1995-03-30 under 510(k) number K934178. 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 ACCUSCREEN 17-HYDROXYPROGESTERONE?

ACCUSCREEN 17-HYDROXYPROGESTERONE is a medical device that received FDA 510(k) clearance on 1995-03-30. The listed applicant is Neometrics, Inc.. The 510(k) number is K934178.

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

ACCUSCREEN 17-HYDROXYPROGESTERONE received FDA 510(k) clearance on 1995-03-30, under 510(k) number K934178.

Who is the listed applicant for ACCUSCREEN 17-HYDROXYPROGESTERONE?

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

What is the FDA product code for ACCUSCREEN 17-HYDROXYPROGESTERONE?

The FDA product code for ACCUSCREEN 17-HYDROXYPROGESTERONE is JLX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Neometrics, 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.

K123439NEO ERCP GUIDEWIREK101729NEOWIRE PTA/PTCA GUIDEWIREK070150VASCUPUNCTURE PICC GUIDEWIREK043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREK040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGK033321SELECTIVA SB GUIDEWIRE

View all 17 devices →

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.

↑