FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
K Number: K852841
·
Decision Jul 24, 1985
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
42
Review Days
19
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Basic Information
- Device Name
- RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
- K Number
- K852841
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Smithkline Diagnostics, Inc.
- Date Received
- July 5, 1985
- Decision Date
- July 24, 1985
- Product Code
- GTZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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Other Clearances by Smithkline Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961062 | FLEXSURE OBT | Nov 6, 1996 | Substantially Equivalent |
| K960183 | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) | Jun 7, 1996 | Substantially Equivalent |
| K934863 | FLEXSURE HP | May 18, 1994 | Substantially Equivalent |
| K880499 | HEMOCCULT SENSITIVE TEST | May 23, 1988 | Substantially Equivalent |
| K875131 | (SKD) CHOLESTEROL TEST KIT | Mar 1, 1988 | Substantially Equivalent |
| K862849 | HEMOCCULT WIPE TEST | Dec 9, 1986 | Substantially Equivalent |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | Mar 5, 1986 | Substantially Equivalent |
| K821884 | GASTROCCULT TM | Oct 8, 1982 | Substantially Equivalent |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | Jun 22, 1982 | Substantially Equivalent |
| K821184 | SPIN CHEM REAGENTS & STANDARDS | May 24, 1982 | Substantially Equivalent |