FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT— 510(k) K844347
Substantially EquivalentFisher Diagnostics
FDA 510(k) clearance K844347 for FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT, Substantially Equivalent on 1985-01-23. Applicant: Fisher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Fisher Diagnostics
- Product code
- Code JHJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
Recent devices under product code JHJ
view allMore clearances from Fisher Diagnostics
view all- K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
- K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN
- K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
- K042924 — ARCHITECT STAT MYO IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.