Terragene Chemdye— 510(k) K200272
Substantially EquivalentTerragene S.A.
FDA 510(k) clearance K200272 for Terragene Chemdye, Substantially Equivalent on 2020-06-30. Applicant: Terragene S.A.. Device class: 2.
Clearance details
- Applicant
- Terragene S.A.
- Product code
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alvear, AR
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More clearances from Terragene S.A.
view all- K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) +1 more
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- DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
- K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- K221641 — Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
Data sourced from openFDA. This site is unofficial and independent of the FDA.