FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ATS TB RAPID STAIN SET PRODUCT #034-45
K Number: K890148
·
Decision Jan 24, 1989
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
3
Applicant Total
18
Review Days
11
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Basic Information
- Device Name
- ATS TB RAPID STAIN SET PRODUCT #034-45
- K Number
- K890148
- 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
- January 13, 1989
- Decision Date
- January 24, 1989
- Product Code
- ICL
- 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 |
|---|---|---|---|
| ICL | Carbol Fuchsin | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ICL), ordered by most recent decision date.
CARBOL-FUCHSIN, ZIEHL-NEEDSEN
FDA 510(k)
FDA Class 1
·Hematology
STAINS, COUNTERSTAINS & GEN. PURPOSE
FDA 510(k)
FDA Class 1
·Hematology
HISTOCHEMICAL AFB DEMONSTRATION
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Alpha-Tec Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053257 | PARA-PRO FC50 | May 12, 2006 | Substantially Equivalent |
| K890861 | ATS DOBELL & O'CONNOR'S IODINE | Mar 23, 1989 | Substantially Equivalent |
| K890020 | ATS LUGOL'S IODINE SOLUTION | Feb 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 |