510(k) K870945
- Device
- RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
- Applicant
- OXOID U.S.A., INC.
- 510(k) number
- K870945
- Product code
- JTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-10
- Date received
- 1987-03-09
- Regulation
- 866.2160
- Classification name
- Plasma, Coagulase, Human, Horse And Rabbit
- 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#
- 1025402
- 8010383
- 1924669
- 1119779
- 2022807
- 8020667
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JTL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950706 | DRYSLIDE COAGULASE | Difco Laboratories, Inc. | 1995-05-16 |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | Immuno-Mycologics, Inc. | 1988-08-25 |
| K861312 | LYFO-KWIK (TM) COAGULASE PLASMA | Micro-Bio-Logics | 1986-04-18 |
| K840553 | HEMASTAPH | Remel Co. | 1984-04-13 |
| K833988 | API STAPHASE III | Analytical Products, Inc. | 1983-12-22 |
| K833858 | COAGULASE PLASMA, HORSE & RABBIT EDTA | Otisville Biotech, Inc. | 1983-12-08 |
| K822988 | COAGULASE PLASMA-CITRATED & EDTA | American Scientific Products | 1982-11-05 |
| K820177 | COAGULASE PLASMA | Quadroma, Inc. | 1982-02-05 |
| K812602 | RABBIT COAGULASE PLASMA | Dutchland Laboratories, Inc. | 1981-09-29 |
| K811982 | STAPHASE* | Analytical Products, Inc. | 1981-07-28 |
| K792235 | COAGULASE PLASMA | Remel Co. | 1979-12-07 |
Legacy Summary#
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FDA Review#
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