510(k) K771144
- Device
- RHODAMINE-CONJUGATED ANTISERUM
- Applicant
- Kent Laboratories, Inc.
- 510(k) number
- K771144
- Product code
- DBY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-14
- Date received
- 1977-06-27
- Regulation
- 866.5520
- Classification name
- Fab, Rhodamine, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DBY#
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|---|---|---|---|
| K022067 | CONVOY ADVANCED DELIVERY SHEATH | Boston Scientific | 2002-09-11 |
| K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Baylis Medical Co., Inc. | 2002-02-22 |
| K013304 | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-01-02 |
| K013282 | GORE INTRODUCER SHEATH | W. L. Gore & Associates, Inc. | 2001-12-14 |
| K013866 | CONVOY ADVANCED DELIVERY SHEATH KIT | Boston Scientific | 2001-12-14 |