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FDA 510(k)

DELFIA(R) HGH KIT

K-Number: K930484 · 1993-05-11

ApplicantWallac OY
Decision Date1993-05-11
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA(R) HGH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K930484. The device is classified under product code CFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELFIA(R) HGH KIT?

DELFIA(R) HGH KIT is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Wallac OY. The 510(k) number is K930484.

When did DELFIA(R) HGH KIT receive FDA 510(k) clearance?

DELFIA(R) HGH KIT received FDA 510(k) clearance on 1993-05-11, under 510(k) number K930484.

Who is the listed applicant for DELFIA(R) HGH KIT?

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

What is the FDA product code for DELFIA(R) HGH KIT?

The FDA product code for DELFIA(R) HGH KIT is CFL.

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Other records listing Wallac OY 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.

K131284GSP NEONATAL BIOTINIDASE KITK100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITK071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BK070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

View all 21 devices →

Related Devices (Code: CFL)

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.

K972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYSealite Sciences, Inc.K971353DSL ACTIVE NON-EXTRACTION IGF-I ELISADiagnostic Systems Laboratories, Inc.K970701DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)Diagnostic Systems Laboratories, Inc.K962758DSL 9100 IGF-II IRMADiagnostic Systems Laboratories, Inc.K961678HUMAN GROWTH HORMONE IMMUNOASSAY KITNichols Institute DiagnosticsK961172DSL ACTIVE NON-EXTRACTION IGF-I IRMADiagnostic Systems 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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