FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI
K Number: K812188
·
Decision Aug 31, 1981
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
9
Applicant Total
28
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI
- K Number
- K812188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3165
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- American Scientific Products
- Date Received
- August 3, 1981
- Decision Date
- August 31, 1981
- Product Code
- GMD
- 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 |
|---|---|---|---|
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMD), ordered by most recent decision date.
CRAG LATERAL FLOW ASSAY (LFA)
FDA 510(k)
FDA Class 2
·Microbiology
CRAG LATERAL FLOW ASSAY (CRAG LFA)
FDA 510(k)
FDA Class 2
·Microbiology
CRYPTO-LEX SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
FDA 510(k)
FDA Class 2
·Microbiology
YA-CRYPTO ANTIBODY TUBE AGGLUTINATION
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by American Scientific Products
| K Number | Device Name | ||
|---|---|---|---|
| K864824 | INFECTIOUS TISSUE KIT | Dec 24, 1986 | Substantially Equivalent |
| K844042 | BLOOD DILUTION VIAL | Oct 23, 1984 | Substantially Equivalent |
| K831634 | GLUCOSE REAGENT B6360-11 | Jul 19, 1983 | Substantially Equivalent |
| K831625 | UREA NITROGEN-BUN-REAGENTS B6360-12 | Jul 7, 1983 | Substantially Equivalent |
| K831626 | UREA NITROGEN-BUN-REAGENTS B6370-11A | Jul 7, 1983 | Substantially Equivalent |
| K831628 | CREATININE REAGENTS B6370-13 | Jul 6, 1983 | Substantially Equivalent |
| K831624 | GLUCOSE REAGENT KITS-B6370-10A | Jul 6, 1983 | Substantially Equivalent |
| K831627 | CREATININE REAGENTS B6360-10 | Jul 6, 1983 | Substantially Equivalent |
| K831569 | REAGENT CUPS | Jun 30, 1983 | Substantially Equivalent |
| K831571 | ROTOR | Jun 30, 1983 | Substantially Equivalent |