Ultimate Direct & Total Bilirubin Contro
FDA 510(k) K802068 · Beckman Instruments, Inc.
510(k) numberK802068
Submission
- Device name
- Ultimate Direct & Total Bilirubin Contro
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- August 27, 1980
- Decision date
- October 10, 1980
- 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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Questions and answers
When was Ultimate Direct & Total Bilirubin Contro cleared by the FDA?
Ultimate Direct & Total Bilirubin Contro (K802068) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 44 days after the submission was received.
What is the product code of K802068?
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.