510(k) K881477
- Device
- HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED
- Applicant
- STAT PATH
- 510(k) number
- K881477
- Product code
- KEL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-18
- Date received
- 1988-04-07
- Regulation
- 864.4010
- Classification name
- Adhesive, Albumin-based
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- R BOSTWICK
- Address
- P.O. Box 6 Riderwood MD US 21139 21139
FDA Registration Numbers#
- 2025606
- 3008174888
- 2013736
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KEL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890022 | ATS MAYER'S ALBUMIN | Alpha-Tec Systems, Inc. | 1989-01-10 |
Legacy Summary#
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FDA Review#
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