FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ATS PARASITOLOGY STAIN CONTROL SLIDE
K Number: K823705
·
Decision Jan 7, 1983
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
26
Applicant Total
18
Review Days
29
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Basic Information
- Device Name
- ATS PARASITOLOGY STAIN CONTROL SLIDE
- K Number
- K823705
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Alpha-Tec Systems, Inc.
- Date Received
- December 9, 1982
- Decision Date
- January 7, 1983
- Product Code
- LJG
- Advisory Committee
- Microbiology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| LJG | Quality Control Slides | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |