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FDA 510(k)

DELFIA(R) 17 -OH-PROGESTERON KIT

K-Number: K912026 · 1991-06-25

ApplicantPharmacia Diagnostics, Inc.
Decision Date1991-06-25
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA(R) 17 -OH-PROGESTERON KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-06-25 under 510(k) number K912026. 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 DELFIA(R) 17 -OH-PROGESTERON KIT?

DELFIA(R) 17 -OH-PROGESTERON KIT is a medical device that received FDA 510(k) clearance on 1991-06-25. The listed applicant is Pharmacia Diagnostics, Inc.. The 510(k) number is K912026.

When did DELFIA(R) 17 -OH-PROGESTERON KIT receive FDA 510(k) clearance?

DELFIA(R) 17 -OH-PROGESTERON KIT received FDA 510(k) clearance on 1991-06-25, under 510(k) number K912026.

Who is the listed applicant for DELFIA(R) 17 -OH-PROGESTERON KIT?

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

What is the FDA product code for DELFIA(R) 17 -OH-PROGESTERON KIT?

The FDA product code for DELFIA(R) 17 -OH-PROGESTERON KIT is JLX.

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Other records listing Pharmacia Diagnostics, 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.

K921011PHARMACIA CMV IGM ELISAK920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNOK915348EBV-VCA IGM ELISAK914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSK902793RUBELLA IGGK902792TOXOPLASMA GONDII IGG

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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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