Bilirubin Plus/Pediatric Controls
FDA 510(k) K943290 · Medi-Tech, Inc.
510(k) numberK943290
Submission
- Device name
- Bilirubin Plus/Pediatric Controls
- Applicant
- Medi-Tech, Inc.
Ventura, CA, US - Received
- July 8, 1994
- Decision date
- September 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K922990 | Hemodialysis BathKPO · Traditional | 09/12/1994SE |
| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
| K895819 | Modified Labeling to the Spand-Gel Granulated GelKMF · Traditional | 11/02/1989SN |
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Questions and answers
When was Bilirubin Plus/Pediatric Controls cleared by the FDA?
Bilirubin Plus/Pediatric Controls (K943290) received a 510(k) decision of Substantially Equivalent on September 14, 1994, 68 days after the submission was received.
What is the product code of K943290?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.