510(k) K780962
- Device
- AUTOMATED ENZYME
- Applicant
- HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
- 510(k) number
- K780962
- Product code
- KSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-07-27
- Date received
- 1978-06-12
- Regulation
- 864.9400
- Classification name
- Solution, Stabilized Enzyme
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017237798
- 1034569
- 9681576
- 3016014873
- 9610824
- 3006261638
- 3011683976
- 3004910133
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KSK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Gamma Biologicals, Inc. | 1982-03-04 |
| K813404 | FREEZE DRIED FICIN | Biological Corp. of America | 1982-02-10 |
| K810803 | FREEZE DRIED PAPAIN | Biological Corp. of America | 1981-07-21 |
| K760123 | AUTOZYME | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Legacy Summary#
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FDA Review#
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