510(k) K955115
- Device
- VENOM TIEM REAGENT
- Applicant
- MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
- 510(k) number
- K955115
- Product code
- JCO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-03
- Date received
- 1995-11-09
- Regulation
- 864.8100
- Classification name
- Bothrops Atrox Reagent
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL D BICK
- Address
- 6025 Nicolle St. Ventura CA US 93003 93003
FDA Registration Numbers#
- 9710666
- 9610806
- 2245451
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JCO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932787 | BATROXOBIN REAGENT | Behring Diagnostics, Inc. | 1993-11-29 |
| K896033 | FDP COLLECTION TUBES | Medical Diagnostic Technologies, Inc. | 1989-10-27 |
| K852519 | DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE | E.I. Dupont DE Nemours & Co., Inc. | 1985-08-12 |
| K843207 | REPTILASE -PC | Bio/Data Corp. | 1984-10-23 |
| K840210 | REPTILASE-R HA35 | Wellcome Diagnostics | 1984-04-23 |
| K780355 | ATROXIN | Sigma Chemical Co. | 1978-04-18 |
Legacy Summary#
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FDA Review#
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