FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INCSTAR ACTH IRMA
K Number: K940271
·
Decision Aug 2, 1994
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
29
Applicant Total
58
Review Days
193
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
- INCSTAR ACTH IRMA
- K Number
- K940271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1025
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Incstar Corp.
- Date Received
- January 21, 1994
- Decision Date
- August 2, 1994
- Product Code
- CKG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CKG | Radioimmunoassay, Acth | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CKG), ordered by most recent decision date.
IDS ACTH II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Incstar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K963289 | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY | May 1, 1997 | Substantially Equivalent |
| K963296 | INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) | Dec 16, 1996 | Substantially Equivalent |
| K963297 | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) | Dec 16, 1996 | Substantially Equivalent |
| K960367 | INCSTAR RUBELLA IGG ELISA ASSAY | Oct 24, 1996 | Substantially Equivalent |
| K960358 | INCSTAR RUBELLA IGG FAST ELISA ASSAY | Oct 24, 1996 | Substantially Equivalent |
| K960434 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 | Oct 17, 1996 | Substantially Equivalent |
| K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA | Sep 25, 1996 | Substantially Equivalent |
| K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY | Jul 24, 1996 | Substantially Equivalent |
| K955363 | INCSTAR HSZ I/II IGG ELISA ASSAY | Jul 24, 1996 | Substantially Equivalent |
| K955361 | INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY | Jul 22, 1996 | Substantially Equivalent |