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FDA 510(k)

NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT

K-Number: K911839 · 1991-06-18

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date1991-06-18
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. It received FDA 510(k) clearance on 1991-06-18 under 510(k) number K911839. 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 NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT?

NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT is a medical device that received FDA 510(k) clearance on 1991-06-18. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K911839.

When did NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT receive FDA 510(k) clearance?

NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT received FDA 510(k) clearance on 1991-06-18, under 510(k) number K911839.

Who is the listed applicant for NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT?

The FDA 510(k) record lists Pantex, Div. Bio-Analysis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT?

The FDA product code for NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT is JLX.

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Other records listing Pantex, Div. Bio-Analysis, 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.

K102841PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAYK942658NEOSCREEN ELISA TSHK914107PROLACTIN IRMA IMMUNOMAGK912804FSH IRMA IMMUNOMAGK911050LH IRMA IMMUNOMAGK910717PANTEX IRMA LH 1251 KIT

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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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