IMAGEN— 510(k) K943557
Substantially EquivalentDako Diagnostics , Ltd.
FDA 510(k) clearance K943557 for IMAGEN, Substantially Equivalent on 1995-01-09. Applicant: Dako Diagnostics , Ltd.. Device class: 1.
Clearance details
- Applicant
- Dako Diagnostics , Ltd.
- Product code
- Code GQS
- Device class
- Class 1
- Regulation
- 21 CFR 866.3400
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridgeshire, GB
Recent devices under product code GQS
view all- K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
- K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN
- K884193 — PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
- K884194 — PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
- K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2
More clearances from Dako Diagnostics , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.