510(k) K770914
- Device
- INCUBATOR, PORTABLE, ACT-STAT
- Applicant
- Thermolyne Corp.
- 510(k) number
- K770914
- Product code
- KQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-04
- Date received
- 1977-05-19
- Regulation
- 864.5400
- Classification name
- Instrument, Coagulation
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3002721930
- 1181121
- 1220649
- 1217183
Source Documents#
510(k) summary PDF not indicated by FDA
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| K902614 | ELVI 828 DIGICLOT MULTISCAN | Logos Scientific, Inc. | 1990-11-08 |
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| K862047 | COAGULATOR (8 CHANNEL) | Med USA | 1986-09-29 |
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| K823131 | KOAGULAB 40-A AUTOMATED COAGULATION SYS | Ortho Diagnostic Systems, Inc. | 1982-12-09 |
| K812906 | ELVI BICLOT 816 | Volu Sol Medical Industries | 1982-07-22 |
| K791587 | ELVI 810 CLOTSCANNER | Volu Sol Medical Industries | 1979-09-17 |