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FDA 510(k)

ALLERGENTICS TOTAL IGE/THEOPHYLLINE

K-Number: K842970 · 1984-08-29

ApplicantAllergenetics
Decision Date1984-08-29
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALLERGENTICS TOTAL IGE/THEOPHYLLINE is the device name listed in this FDA 510(k) record. The listed applicant is Allergenetics. It received FDA 510(k) clearance on 1984-08-29 under 510(k) number K842970. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLERGENTICS TOTAL IGE/THEOPHYLLINE?

ALLERGENTICS TOTAL IGE/THEOPHYLLINE is a medical device that received FDA 510(k) clearance on 1984-08-29. The listed applicant is Allergenetics. The 510(k) number is K842970.

When did ALLERGENTICS TOTAL IGE/THEOPHYLLINE receive FDA 510(k) clearance?

ALLERGENTICS TOTAL IGE/THEOPHYLLINE received FDA 510(k) clearance on 1984-08-29, under 510(k) number K842970.

Who is the listed applicant for ALLERGENTICS TOTAL IGE/THEOPHYLLINE?

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

What is the FDA product code for ALLERGENTICS TOTAL IGE/THEOPHYLLINE?

The FDA product code for ALLERGENTICS TOTAL IGE/THEOPHYLLINE is JJY.

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Other records listing Allergenetics 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.

K851512ALLERGENETICS IGE FAST TESTK842969ALLERGENETICS ALLER-SPECIFIC IGE SERUMK833418CHYMOFAST TESTK834594TOTAL IGE FAST TESTK833419LABELED 125I ANTI-IGEK834244THEOFAST TEST KIT FOR QUANTITATIVE THEO

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Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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