FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ATS DOBELL & O'CONNOR'S IODINE
K Number: K890861
·
Decision Mar 23, 1989
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
39
Applicant Total
18
Review Days
30
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Basic Information
- Device Name
- ATS DOBELL & O'CONNOR'S IODINE
- K Number
- K890861
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Alpha-Tec Systems, Inc.
- Date Received
- February 21, 1989
- Decision Date
- March 23, 1989
- Product Code
- JTS
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| JTS | Stains, Microbiologic | FDA class 1 | Hematology |
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Other Clearances by Alpha-Tec Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053257 | PARA-PRO FC50 | May 12, 2006 | Substantially Equivalent |
| K890020 | ATS LUGOL'S IODINE SOLUTION | Feb 24, 1989 | Substantially Equivalent |
| K890148 | ATS TB RAPID STAIN SET PRODUCT #034-45 | Jan 24, 1989 | Substantially Equivalent |
| K890022 | ATS MAYER'S ALBUMIN | Jan 10, 1989 | Substantially Equivalent |
| K883048 | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | Aug 17, 1988 | Substantially Equivalent |
| K883049 | ATS PARA-SET IODINE ALCOHOL SOLUTION | Aug 17, 1988 | Substantially Equivalent |
| K883062 | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | Aug 4, 1988 | Substantially Equivalent |
| K881949 | ATS NAC-PAC SET | May 25, 1988 | Substantially Equivalent |
| K881879 | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | May 13, 1988 | Substantially Equivalent |
| K881698 | ATS PVA FIXATIVE SOLUTION | May 13, 1988 | Substantially Equivalent |