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FDA 510(k)

LH IRMA IMMUNOMAG

K-Number: K911050 · 1991-04-12

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date1991-04-12
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LH IRMA IMMUNOMAG 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 1991-04-12 under 510(k) number K911050. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LH IRMA IMMUNOMAG?

LH IRMA IMMUNOMAG is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K911050.

When did LH IRMA IMMUNOMAG receive FDA 510(k) clearance?

LH IRMA IMMUNOMAG received FDA 510(k) clearance on 1991-04-12, under 510(k) number K911050.

Who is the listed applicant for LH IRMA IMMUNOMAG?

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 LH IRMA IMMUNOMAG?

The FDA product code for LH IRMA IMMUNOMAG is CEP.

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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 IMMUNOMAGK911839NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KITK910717PANTEX IRMA LH 1251 KIT

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Related Devices (Code: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.

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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