510(k) K934966
- Device
- SPQ PAL CONTROL LEVEL II
- Applicant
- INCSTAR CORP.
- 510(k) number
- K934966
- Product code
- DDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-11
- Date received
- 1993-10-15
- Regulation
- 866.5060
- Classification name
- Prealbumin, Fitc, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY ELLEN BEST
- Address
- 1990 Insustrial Blvd. P.O. Box 285 Stillwater MN US 55082 55082
FDA Registration Numbers#
- 1836161
- 3003761012
- 2517506
- 2050010
- 2050012
- 9680746
Source Documents#
Other 510(k) Records For Product Code DDS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972812 | RAICHEM PREALBUMIN SPIA | Hemagen Diagnostics, Inc. | 1997-08-28 |
| K964781 | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | Beckman Instruments, Inc. | 1997-05-09 |
| K854811 | ICS PAB PREALBUMIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1986-01-24 |
Legacy Summary#
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FDA Review#
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