510(k) K844836
- Device
- HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
- Applicant
- EDWARD WECK, INC.
- 510(k) number
- K844836
- Product code
- GWD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-23
- Date received
- 1984-12-12
- Regulation
- 866.3220
- Classification name
- Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFREY GREEN
- Address
- P.O. Box 12600 Weck Dr. Research Triangle Pa NC US 27709 27709
FDA Registration Numbers#
- 2031468
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K873299 | MERIFLUOR(TM)-GIARDIA | Meridian Diagnostics, Inc. | 1987-09-16 |
Legacy Summary#
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FDA Review#
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