510(k) K842931
- Device
- DRABKIN REAGENT
- Applicant
- E K IND., INC.
- 510(k) number
- K842931
- Product code
- KAG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-09-21
- Date received
- 1984-07-25
- Regulation
- 878.1800
- Classification name
- Holder, Speculum, Ent
- Medical specialty
- General & Plastic Surgery
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8030607
- 9613926
- 9681840
- 9612278
- 9681540
- 3004530184
- 8010890
- 1932180
- 3011137372
- 3003597504
- 3007773213
- 8010433
- 3010041511
- 8040278
- 3005440795
- 3002807115
- 3008280196
- 3008338766
- 3002834291
- 3003675041
- 1313525
- 3008902714
- 1836161
- 9610612
- 1055890
- 9615857
- 9613083
- 8043496
- 3009513193
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KAG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822857 | CPI PRINTER | Cardiac Pacemakers, Inc. | 1983-01-08 |
Legacy Summary#
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FDA Review#
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