510(k) K781355
- Device
- ICS NORMAL CONTROL SERUM
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K781355
- Product code
- DGR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-31
- Date received
- 1978-08-07
- Regulation
- 866.5700
- Classification name
- Whole Human Serum, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8030124
- 2250051
- 3012963943
- 3009189893
- 3015376545
- 3017237798
- 1319681
- 1424263
- 3000308930
- 3013059683
- 3003935253
- 3002642396
- 3004375571
- 9610099
- 3010194621
- 3019906
- 3003423869
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DGR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961544 | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 | Consolidated Technologies, Inc. | 1996-09-24 |
| K902220 | PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL | Boehringer Mannheim Corp. | 1990-09-05 |
| K865014 | LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II | Bio-Rad | 1987-01-09 |
| K790298 | RADIOASSAY, CONTROL SERUM I, II, III | Kallestad Laboratories, Inc. | 1979-04-04 |
Legacy Summary#
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FDA Review#
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