Tri-Level Ligand Control
FDA 510(k) K873450 · Ciba Corning Diagnostics Corp.
510(k) numberK873450
Submission
- Device name
- Tri-Level Ligand Control
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- August 27, 1987
- Decision date
- September 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
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Questions and answers
When was Tri-Level Ligand Control cleared by the FDA?
Tri-Level Ligand Control (K873450) received a 510(k) decision of Substantially Equivalent on September 21, 1987, 25 days after the submission was received.
What is the product code of K873450?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.