510(k) K901537
- Device
- MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
- Applicant
- PB DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K901537
- Product code
- LET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-12
- Date received
- 1990-04-02
- Regulation
- 862.3660
- Classification name
- Fluorescent Immunoassay, Phenobarbital
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LORI BARANAUSKAS
- Address
- 151 University Ave. Westwood MA US 02090 02090
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LET #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K865000 | IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS | Sclavo, Inc. | 1987-02-06 |
| K842592 | AMES TDA PHENOBARBITAL TEST | Miles Laboratories, Inc. | 1984-08-17 |
| K830701 | STRATUS PHENOBARBITAL FLUOROMETRIC ENZ | American Dade | 1983-05-13 |
| K821408 | PHENOBARBITAL FLUORESCENT IMMUNO | American Diagnostic Corp. | 1982-05-24 |
| K820188 | PHENOBARBITAL ASSAY | Syva Co. | 1982-02-05 |
| K810994 | AMES TDA TM PHENOBARBITAL TEST | Miles Laboratories, Inc. | 1981-04-29 |
| K802255 | AMES TDA PHENOBARBITAL TEST | Miles Laboratories, Inc. | 1980-09-26 |
Legacy Summary#
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FDA Review#
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