FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MERITECASTREP (TM)
K Number: K821100
·
Decision May 13, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
92
Review Days
23
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Basic Information
- Device Name
- MERITECASTREP (TM)
- K Number
- K821100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Meridian Diagnostics, Inc.
- Date Received
- April 20, 1982
- Decision Date
- May 13, 1982
- 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 Meridian Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | Dec 10, 1999 | Substantially Equivalent |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | Aug 9, 1999 | Substantially Equivalent |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | Jun 25, 1999 | Substantially Equivalent |
| K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | Jun 25, 1999 | Substantially Equivalent |
| K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA | Dec 17, 1998 | Substantially Equivalent |
| K982764 | PREMIER CRYPTOSPORIDIUM | Dec 3, 1998 | Substantially Equivalent |
| K982711 | PREMIER GIARDIA | Nov 25, 1998 | Substantially Equivalent |
| K980076 | PREMIER PLATINUM HPSA | May 12, 1998 | Substantially Equivalent |
| K980077 | PARA-PAK SPINCON | Apr 2, 1998 | Substantially Equivalent |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | Aug 20, 1997 | Substantially Equivalent |