Automated Enzyme
FDA 510(k) K780962 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK780962
Submission
- Device name
- Automated Enzyme
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- June 12, 1978
- Decision date
- July 27, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSK – Solution, Stabilized Enzyme
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9400
- Specialty
- Hematology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K813342 | Gamma Chloroquine Diphosphate SolutionKSK · Traditional | Gamma Biologicals, Inc. | 03/04/1982SE |
| K813404 | Freeze Dried FicinKSK · Traditional | Biological Corp. of America | 02/10/1982SE |
| K810803 | Freeze Dried PapainKSK · Traditional | Biological Corp. of America | 07/21/1981SE |
| K760123 | AutozymeKSK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/20/1976SE |
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| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
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| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | 08/31/1978SE |
| K780785 | Dilutor TransporterJQW · Traditional | 06/14/1978SE |
Questions and answers
When was Automated Enzyme cleared by the FDA?
Automated Enzyme (K780962) received a 510(k) decision of Substantially Equivalent on July 27, 1978, 45 days after the submission was received.
What is the product code of K780962?
The FDA product code is KSK – Solution, Stabilized Enzyme, a Class II (moderate risk) device regulated under 21 CFR 864.9400.