510(k) K855235
- Device
- DIAGNOSTIC REAGENT PET-RPLA
- Applicant
- OXOID U.S.A., INC.
- 510(k) number
- K855235
- Product code
- JSP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-04
- Date received
- 1985-12-31
- Regulation
- 866.2660
- Classification name
- Kit, Anaerobic Identification
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUTH KEMP
- Address
- 9017 Red Branch Rd. Columbia MD US 21045 21045
FDA Registration Numbers#
- 3013718871
- 3003750284
- 1924669
- 3009637528
- 8010096
- 2919016
- 9615754
- 1950204
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945489 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 |
| K945488 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 |
| K945487 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-05-11 |
| K944528 | BBLCRYSTAL ANAEROBE ID SYSTEM | Becton Dickinson Microbiology Systems | 1995-03-07 |
| K910666 | VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION | Vitek Systems, Inc. | 1991-04-03 |
| K900996 | VITEK ANAEROBE IDENTIFICATION CARD | Vitek Systems, Inc. | 1990-05-11 |
| K881380 | B. FRAGTEX | American Biomedical Products, Inc. | 1988-10-06 |
| K882960 | IDS RAPID ANA SYSTEM | Innovative Diagnostic Systems, Inc. | 1988-08-12 |
| K862332 | ANAEROBE RAPID CHROMOGENIC ID PANEL | American Micro Scan | 1986-08-27 |
| K850052 | ANAEROBE KIT | Austin Biological Laboratories | 1985-03-05 |
| K843686 | AMS ANA CARD | Vitek Systems, Inc. | 1984-12-12 |
| K831032 | API ANAIDENT | Analytical Products, Inc. | 1983-05-05 |
| K830964 | ANAEROBE MIC/ID TEMPLATE, & TAXONOMY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-05-04 |
| K820483 | IDA RAPID O2A SYSTEM | Innovative Diagnostic Systems, Inc. | 1982-03-15 |
| K802626 | ANAIROBE-TEK | Flow Laboratories, Inc. | 1980-11-12 |
Legacy Summary#
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FDA Review#
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