FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYTO-STAIN
K Number: K830625
·
Decision Mar 24, 1983
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
0
Applicant Total
33
Review Days
23
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Basic Information
- Device Name
- CYTO-STAIN
- K Number
- K830625
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1870
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Richard-Allan Medical Ind., Inc.
- Date Received
- March 1, 1983
- Decision Date
- March 24, 1983
- Product Code
- HJQ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HJQ | Stereoscope, Ac-Powered | FDA class 1 | Ophthalmic |
Other Clearances by Richard-Allan Medical Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931879 | REFLEX HTR | Mar 24, 1994 | Substantially Equivalent |
| K924200 | REFLEX(R) ESC | Feb 22, 1994 | Substantially Equivalent |
| K926297 | REFLEX ESI | Oct 15, 1993 | Substantially Equivalent |
| K924761 | STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD | Apr 20, 1993 | Substantially Equivalent |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | May 3, 1990 | Substantially Equivalent |
| K896262 | TITANIUM LIGATING CLIPS | Jan 2, 1990 | Substantially Equivalent |
| K890314 | PROTECTOR (SURGICAL INSTRUMENT) | Feb 27, 1989 | Substantially Equivalent |
| K873309 | REFLEX(TM) CA-T CLIP APPLIER | Nov 27, 1987 | Substantially Equivalent |
| K862404 | REFLEX(TM) CLIP APPLIER | Jul 23, 1986 | Substantially Equivalent |
| K862223 | MICRO THIN* PARAFFIN | Jun 17, 1986 | Substantially Equivalent |