Exo-Antigen Identification System Cat.# EX1001
FDA 510(k) K880029 · Immuno-Mycologics, Inc.
510(k) numberK880029
Submission
- Device name
- Exo-Antigen Identification System Cat.# EX1001
- Applicant
- Immuno-Mycologics, Inc.
Norman, OK, US - Received
- January 5, 1988
- Decision date
- February 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KFH – Antiserum, Positive Control, Blastomyces Dermatitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3060
- Specialty
- Microbiology
Other 510(k)s with product code KFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K792685 | Blastomyces Dermatitidis, AntiserumKFH · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K792681 | Blastomyces Dermatitidis Pos/ControlKFH · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K760833 | Anti-Blastomyces Control Serum (Yeast)KFH · Traditional | I M, Inc. | 11/01/1976SE |
More from I M, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K120946 | Alpha Cryptococcal Antigen EiaMDU · Traditional | 12/17/2012SE |
| K112422 | Crag Lateral Flow Assay (Lfa)GMD · Traditional | 03/28/2012SE |
| K102286 | Crag Lateral Flow Assay (Crag Lfa)GMD · Traditional | 07/20/2011SE |
| K101407 | Alpha Histoplasma Antigen Eia Model HAG102MIZ · Traditional | 07/19/2011SE |
| K883333 | Rabbit Plasma Fibrinogen (RPF) SupplementJTL · Traditional | 08/25/1988SE |
| K843286 | Ei-Candida Enzyme Immunoassay EI1001LRF · Traditional | 10/01/1984SE |
| K831918 | La-Staph Identification SystemJWX · Traditional | 06/08/1983SE |
| K830837 | La-Histo Antibody System #Hl 1001GMJ · Traditional | 05/05/1983SE |
| K810510 | Ya-Crypto Antibody Tube AgglutinationGMD · Traditional | 03/20/1981SE |
| K802427 | La-Sporo Antibody SystemGMA · Traditional | 10/31/1980SE |
Questions and answers
When was Exo-Antigen Identification System Cat.# EX1001 cleared by the FDA?
Exo-Antigen Identification System Cat.# EX1001 (K880029) received a 510(k) decision of Substantially Equivalent on February 24, 1988, 50 days after the submission was received.
What is the product code of K880029?
The FDA product code is KFH – Antiserum, Positive Control, Blastomyces Dermatitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3060.